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Suggestions within category "Cancer"

26 Study Matches

Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

Cady P Noda, Pharm.D. - cady.noda@vcuhealth.org

Noda, Cady, Ploessl
NCT03964259
HM20016430
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Inclusion Criteria:

• Diagnosis of lymphoma or acute lymphoblastic leukemia
• Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
• Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
• Patients of childbearing potential must have a negative pregnancy test (serum or urine)
• Lactating female patients must agree not to nurse a child while on this trial
• All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:

• Trisomy 21
• History of dialysis within 30 days prior to study registration or currently on dialysis
• Polyuric renal dysfunction
• Pregnancy
• Known or suspected pleural effusion
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Drug: Intravenous fluids
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
High Dose Methotrexate, HDMTX, Intravenous Fluids
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Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Richmond, Virginia Lindsey B Gwaltney, RN - (lbgwaltney@vcu.edu) Cady P Noda, Pharm.D. - (cady.noda@vcuhealth.org)

Study of LYL314 in Aggressive Large B-Cell Lymphoma

Lyell Immunopharma Inc. - clinicaltrials@lyell.com

NCT05826535
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Inclusion Criteria:

• Age 18 years or older at time of informed consent
• Willing and able to provide written informed consent
• Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO 2017): * DLBCL * DLBCL arising from follicular lymphoma (transformed FL, tFL) * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL) * High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement (HGBL) * Grade 3B follicular lymphoma/Large cell follicular lymphoma (FL3B)
• Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3. Prior therapy must have included: * Anti-CD20 monoclonal antibody, and * An anthracycline containing chemotherapy regimen * Participants with tFL must have received at least one of their prior lines of therapy after transformation to DLBCL 4b. Cohort 5 (High-risk first-line) participants must have high-risk large B-cell lymphoma
• Relapsed or refractory disease, defined by the following: * Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation \[ASCT\]). In participants who have only received front-line therapy, progression should be ≤ 12 months of first-line therapy (applicable for Cohort 3) * In patients who received one line of therapy, refractory disease is defined as failure to achieve at least a PR after at least 4 cycles of therapy (applicable for Cohort 3) * In patients who received two or more lines of therapy (Cohorts 1, 2, and 4), refractory disease is defined as failure to achieve a CR to last line of therapy (including CAR T and/or salvage therapy).
• At least 1 measurable lesion (per Lugano classification). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
• Absolute neutrophil count (ANC) ≥ 1000/uL
• Platelet count ≥ 50,000/uL
• Absolute lymphocyte count (ALC) ≥ 200/uL Other protocol-defined criteria apply.
Exclusion Criteria:

• History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years. Participants who have received therapy for a prior malignancy within the prior 3 years, e.g., in the adjuvant setting, are not excluded
• Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis treated at least 8 weeks prior to enrollment will not be excluded for participation if CNS disease is deemed stable at the time of study enrollment
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome, known vascular invasion)
• Received the following therapies in the specified time frame prior to enrollment/leukapheresis
• Any systemic therapy within 2 weeks
• Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)
• Fludarabine within 12 weeks
• Alemtuzumab, bendamustine or antithymocyte globuline (ATG) within 6 months
• Any T cell engager/bispecific antibody therapy such as CD20/CD3 or CD19/CD3 bispecific antibodies within 4 weeks
• Any experimental therapy within 4 weeks or 5 half-lives (whichever is shorter)
• Received radiation therapy within 3 weeks prior to enrollment/leukapheresis
• Experiencing non-hematologic toxicities due to prior therapy. Exceptions include: stable and recovered to grade ≤ 1 or non-clinically significant toxicities such as (1) alopecia, (2) toxicities where Grade 2 is solely defined by participant receiving hormone replacement therapy for endocrinopathies resulting from previous checkpoint inhibitor therapy, (3) Grade 2 lymphopenia, and (4) hearing loss or Grade 2 neuropathy associated with prior treatment with taxanes or platinating agents
• History of allogeneic stem cell or solid organ transplantation
• Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment/leukapheresis
• History of prior genetically modified cell therapy other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel). For all other CAR T cell therapy treatments, discussion with the Sponsor's Medical Monitor is required
• Primary immunodeficiency
• History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. Participants who have other autoimmune condition(s) considered to be associated with underlying malignancy may be enrolled in the study after discussion with and approval of the Medical Monitor. Other protocol-defined criteria apply.
DRUG: LYL314, DRUG: Fludarabine, DRUG: Cyclophosphamide
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma
CAR T-cell, Non-Hodgkin Lymphoma, CD19/20, CD19, CD20, NHL, Diffuse Large B-cell lymphoma, DLBCL, Transformed follicular lymphoma, TFL, Primary mediastinal B-cell lymphoma, PMBCL, High-grade B-cell lymphoma, HGBL, follicular lymphoma Grade 3B, large cell follicular lymphoma, Aggressive B-cell NHL, Refractory Aggressive B-Cell Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cyclophosphamide, Fludarabine, Lymphoma, Follicular, Lymphoma, B-cell, Immunosuppressive Agents, Immunologic Factors, Disease Attributes, Immune System Diseases, Recurrence, PiNACLE
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Augusta University Medical Center Augusta, Georgia
Baylor University Medical Center Dallas, Texas
Cedars-Sinai Medical Center Los Angeles, California
Colorado Blood Cancer Institute Denver, Colorado
Corewell Health Grand Rapids, Michigan
Huntsman Cancer Institute Salt Lake City, Utah
Indiana Blood and Marrow Transplantation Indianapolis, Indiana
Intermountain Healthcare Salt Lake City, Utah
Lehigh Valley Topper Cancer Center Institute Allentown, Pennsylvania
Louisiana State University Health Sciences Center Shreveport, Louisiana
Medical College of Wisconsin Milwaukee, Wisconsin
Montefiore Medical Center The Bronx, New York
Scripps Clinic San Diego, California
Thomas Jefferson University Philadelphia, Pennsylvania
University of California, Los Angeles (UCLA) Medical Center Los Angeles, California
University of California-Irvine Medical Center Irvine, California
University of Cincinnati (UC) Physicians Company, LLC Cincinnati, Ohio
University of Iowa Iowa City, Iowa
University of Louisville Brown Cancer Center Louisville, Kentucky
University of New Mexico Comprehensive Cancer Center Albuquerque, New Mexico
Virginia Commonwealth University-Massey Cancer Center Richmond, Virginia

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Socorro Portella, MD - clinicaltrials@cariboubio.com

NCT04637763
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Inclusion Criteria:
* Age greater than or equal to 18 at the time of enrollment * Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care * Eastern Cooperative Oncology Group performance status 0 or 1 * Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Exclusion Criteria:
* Prior therapy with an anti-CD19 targeting agent * Active or chronic graft versus host disease requiring therapy * Prior allogeneic stem cell transplantation * Central nervous system (CNS) lymphoma, prior CNS malignancy * Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement. * Primary immunodeficiency * Current or expected need for systemic corticosteroid therapy * Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted * Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence * Unwillingness to follow extended safety monitoring
GENETIC: CB-010, DRUG: Cyclophosphamide, DRUG: Fludarabine
Lymphoma, Non-Hodgkin, Relapsed Non Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma, B Cell Non-Hodgkin's Lymphoma
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Study Locations

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Advent Health Orlando, Florida Kristen Wing - (Kristen.Wing@adventhealth.org)
Atlantic Health System Morristown, New Jersey Amanda Hall - (Amandamaria.hall@atlantichealth.org) Salome Greene - (salome.geene@atlantichealth.org)
Banner MD Anderson Cancer Center Gilbert, Arizona Tracy Kliner - (tracy.kliner@bannerhealth.com)
Baylor Charles A. Sammons Cancer Center Dallas, Texas Tarah Satterfield - (Tarah.Satterfield@BSWHealth.org)
Bone and Marrow Transplant Group of Georgia Atlanta, Georgia Melhem Solh, MD - (msolh@bmtga.com)
Chao Family Comprehensive Cancer Center/University of California Irvine Orange, California Blake Johnson - (blakej@hs.uci.edu)
Epworth Healthcare Melbourne, Victoria Dr Costas Yannakou - (costas.yannakou@epworth.org.au) Dr Connie Barlas - (connie.barlas@epworth.org.au)
Georgia Cancer Center at Augusta University Augusta, Georgia Kelly Jenkins - (kejenkins@augusta.edu)
Hackensack Medical Center Hackensack, New Jersey Elizabeth McCarthy - (elizabethl.mccarthy@hmhn.org)
Hadassah Medical Center Jerusalem, Nurit Ben Shmuel - (nuritb@hadassah.org.il)
Holden Comprehensive Cancer Center at the University of Iowa Iowa City, Iowa Umar Farooq - (umar-farooq@uiowa.edu)
HonorHealth Scottsdale, Arizona Research Nurse Navigator - (clinicaltrials@honorhealth.com)
Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah Erin Peterson - (erin.peterson@hci.utah.edu)
MD Anderson Cancer Center Houston, Texas Ly Dsouza - (ldsouza@mdanderson.org)
Medical College of Wisconsin Milwaukee, Wisconsin Roisin McAndrew - (rmcandrew@mcw.edu)
Montefiore Medical Center The Bronx, New York Joel Victor - (jovictor@montefiore.org)
NYU Langone Health New York, New York MARK BOND - (Mark.Bond@nyulangone.org)
Norton Cancer Institute Louisville, Kentucky Tabby Thomas - (StudyStartup@NCIResearch.org)
Ohio State University James Cancer Hospital Columbus, Ohio
Oncology Hematology Care Cincinnati, Ohio Eric Clayton - (Eric.Clayton@usoncology.com)
Oregon Health & Science University Portland, Oregon Richard Maziarz, MD - (MAZIARZR@ohsu.edu)
Rabin Medical Center Petah Tikva, Miri Pinhasov - (miripi@clalit.org.il)
Royal Perth Hospital Perth, Western Australia Megan Margaria - (megan.margaria@health.wa.gov.au) Lisa Forsyth - (lisa.forsyth@health.wa.gov.au)
Swedish Cancer Institute Seattle, Washington
Tel Aviv Medical Center Tel Aviv, Sandrine Harari-Csillag - (sandrinehc@tlvmc.gov.il)
The Sheba Fund for Health Services and Research (R.A.) Tel HaShomer, Kira Lozinsky - (kira.lozinsky@sheba.health.gov.il)
Tufts Medical Center Boston, Massachusetts LaToya Marshall - (latoya.marshall@tuftsmedicine.org)
University of Alabama at Birmingham Birmingham, Alabama
University of Arizona Cancer Center Tucson, Arizona Francois Chu - (fchu@arizona.edu)
University of Arkansas Little Rock, Arkansas Dr. Cesar Gentille Sanchez - (cgentille@uams.edu)
University of California San Diego Moores Cancer Center La Jolla, California Michelle Padilla - (mlp002@health.ucsd.edu)
University of Kentucky Markey Cancer Lexington, Kentucky Yvonne Taul - (Yvonne.Taul@uky.edu)
University of Pennsylvania Philadelphia, Pennsylvania Sunita Nasta - (Sunita.Nasta@pennmedicine.upenn.edu) Michael McNicholas - (Michael.McNicholas@pennmedicine.upenn.edu)
University of Southern California, Norris Comprehensive Cancer Center Los Angeles, California Christine Duran - (Duran_c@med.usc.edu)
Vanderbilt University Medical Center Nashville, Tennessee Dr. Olalekan Oluwole - (olalekan.oluwole@vanderbilt.edu)
Virginia Commonwealth University (VCU) Richmond, Virginia Kristin Lantis - (kllantis@vcu.edu)
Virginia Oncology Associates Norfolk, Virginia Karen McClain - (Karen.mcclain@usoncology.com)
Westmead Hospital Westmead, Dr Kenneth Micklethwaite - (ken.micklethwaite@health.nsw.gov.au) Gillian Huang - (gillian.huang@health.nsw.gov.au)

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma

Study Director - clinicaltrials@beigene.com

NCT06742996
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Inclusion Criteria:
* Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) * Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator * Relapsed or refractory disease after the last line of therapy * Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function
Exclusion Criteria:
* Prior therapy with B-cell lymphoma-2 inhibitor * Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug * Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug * Known central nervous system involvement by lymphoma * Clinically significant cardiovascular disease * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Sonrotoclax, DRUG: Zanubrutinib, DRUG: Placebo
Mantle Cell Lymphoma, B Cell Lymphoma
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax
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Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken
Aidport Sp Z O O Skorzewo,
Antalya Memorial Hospital Dokuma,
Asan Medical Center Seoul,
Atrium Health Levine Cancer Institute (Lci) Charlotte, North Carolina
Atrium Health Wake Forest Baptist Winston-Salem, North Carolina
Auxilio Mutuo Cancer Center San Juan,
Azienda Sanitaria Universitaria Giuliano Isontina Trieste,
Beatson West of Scotland Cancer Centre Glasgow,
Beijing Cancer Hospital Beijing,
Beijing Hospital Beijing,
Box Hill Hospital Box Hill, Victoria
Centre Hospitalier Universitaire Nantes Hotel Dieu Nantes,
Centroricerche Cliniche Di Verona Srl Verona,
Chiba Cancer Center Chiba, Chiba
Christchurch Hospital Christchurch,
Chu Hopital Lyon Sud PierreBenite,
Chu Montpellier Hopital Saint Eloi Montpellier,
Chu Tours Hopital Bretonneau Tours,
Churchill Hospital Oxford University Hospital Nhs Trust Headington,
Clatterbridge Cancer Centre Metropolitan Borough of Wirral,
Cleveland Clinic Florida Weston, Florida
Cleveland Clinic Foundation Cleveland, Ohio
Concord Repatriation General Hospital Concord, New South Wales
Dana Farber Cancer Institute Longwood Medical Center Boston, Massachusetts
Derriford Hospital Plymouth,
Dokkyo Medical University Saitama Medical Center Koshigaya, Saitama
Dunedin Hospital Dunedin Central,
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana
Fudan University Shanghai Cancer Center Shanghai,
Fujian Medical University Union Hospital Fuzhou, Fujian
Fundacao Pio Xii Hospital de Amor de Barretos Barretos,
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude Petrópolis,
GenesisCare North Shore St Leonards, New South Wales
H Puerta de Hierro Majadahonda Majadahonda,
Harbin Medical University Cancer Hospital Harbin,
Hattiesburg Hematology and Oncology Clinic Hattiesburg, Mississippi
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular São Paulo,
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital Hiroshima, Hiroshima
Hokkaido University Hospital Sapporo, Hokkaido
Hospital Aleman CABA,
Hospital Clinic de Barcelona Barcelona,
Hospital Do Cancer de Pernambuco Recife,
Hospital Erasto Gaertner Curitiba,
Hospital Felício Rocho Belo Horizonte,
Hospital Santa Rita de Cassia Afecc Vitória,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital de Clínicas de Porto Alegre Porto AlegreRS,
Ico H Duran I Reynals Barcelona,
Institute of Science Tokyo Hospital Tokyo,
Instituto Joinvilense De Hematologia e Oncologia Joinville,
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst Meldola,
Jiangsu Province Hospital Nanjing, Jiangsu
Jiangxi Province Cancer Hospital Nanchang, Jiangxi
Kagoshima University Hospital Kagoshima, Kagoshima-ken
Kanagawa Cancer Center Yokohama, Kanagawa
Klinikum Chemnitz gGmbH Chemnitz,
Kobe City Medical Center General Hospital KobeShi, Hyōgo
Kocaeli Universitesi Tip Fakultesi Kocaeli,
Kurashiki Central Hospital Kurashikishi, Okayama-ken
Liaoning Cancer Hospital and Institute Shenyang,
Linear Clinical Research Nedlands, Western Australia
Linyi Cancer Hospital Linyi, Shandong
MD Anderson Cancer Center Houston, Texas
Matsuyama Red Cross Hospital Matsuyama,
Mayo Clinic Phoenix Phoenix, Arizona
Mayo Clinic Rochester Rochester, Minnesota
McGlinn Cancer Institute West Reading, Pennsylvania
Memorial Cancer Institute, Memorial Healthcare System Pembroke Pines, Florida
Mission Cancer and Blood Waukee, Iowa
Monash Health Clayton, Victoria
Nanfang Hospital of Southern Medical University Guangzhou, Guangdong
National Hospital Organization Okayama Medical Center Okayama,
Nebraska Cancer Specialists Omaha, Nebraska
Nebraska Cancer Specialists St Francis Grand Island Grand Island, Nebraska
North Shore Hospital Auckland,
Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver, Washington
Ogaki Municipal Hospital Ōgaki, Gifu
Ohio Health Research Institute Columbus, Ohio
Ohio State University Comprehensive Cancer Center Columbus, Ohio
One Clinical Research Nedlands, Western Australia
Ordensklinikum Linz GmbH Elisabethinen Linz,
Osaka Metropolitan University Hospital Osaka,
Osaka Red Cross Hospital Osakashi, Osaka
Ospedale Vito Fazzi, Asl Lecce Leece,
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania
Perth Blood Institute West Perth, Western Australia
Policlinico Sorsola Malpighi, Aou Di Bologna Bologna,
Pratia MCM Kraków Krakow,
Pusan National University Hospital Busan,
Rockingham Hospital Cooloongup, Western Australia
Samsung Medical Center Seoul,
Seoul National University Bundang Hospital Seongnam-si,
Seoul National University Hospital Seoul,
Severance Hospital Yonsei University Health System Seoul,
Shaanxi Provincial Peoples Hospital Xi'an, Shaanxi
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu, Sichuan
Stauferklinikum Schwabisch Gmund Kliniken Ostalb Mutlangen,
Sun Yat Sen University Cancer Center Guangzhou,
Sunshine Coast Hospital and Health Service Birtinya, Queensland
Tauranga Hospital Tauranga,
Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee
Tennessee Oncology Nashville, Tennessee
Texas Oncology Austin Midtown Round Rock, Texas
The Affiliated Hospital of Qingdao University Branch West Coast Qingdao, Shandong
The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu
The Cancer and Hematology Centers Grand Rapids, Michigan
The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi
The Catholic University of Korea, Yeouido St Marys Hospital Yeongdeungpo-gu, Seoul Teugbyeolsi
The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Hangzhou, Zhejiang
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation Bournemouth,
The Valley Hospital, Inc Paramus, New Jersey
Tohoku University Hospital Sendai,
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei
Toyohashi Municipal Hospital Toyohashishi, Aichi-ken
Uk St Poelten Sankt Pölten,
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei
Universidade de Campinas Centro de Hematologia E Hemoterapia Campinas,
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg Salzburg,
University College Hospital London,
University Hospitals Cleveland, Ohio
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore, Maryland
University of Michigan Ann Arbor, Michigan
University of Virginia Charlottesville, Virginia
Uniwersytecki Szpital Kliniczny Nr W Lublinie Lublin,
VCU Massey Cancer Center Richmond, Virginia
Virgina Cancer Specialists Gainesville, Virginia
Washington University School of Medicine St Louis, Missouri
Wellington Regional Hospital (Ccdhb) Wellington,
Westmead Hospital Westmead,
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi Lodz,
Yale University, Yale Cancer Center New Haven, Connecticut
Yokohama Municipal Citizens Hospital Yokohama,
hospital Italiano de Buenos Aires Ciudad Autonoma de,

Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

ctrrecruit@vcu.edu

NCT06002828
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Inclusion Criteria:
* Patient must be \>= 18 years of age at the time of registration * Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL) * Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration * Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration * NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach * Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3 * Patient must be English speaking in order to be able to complete the required QOL forms on this study * NOTE: Sites cannot translate the associated QOL forms * Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma * Patient must have internet access through computer, tablet, or smartphone * Patient must have email address * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
PROCEDURE: Biospecimen Collection, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Advanced Breast Care Center PLLC Warren, Michigan
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate High Tech Medical Park Palos Heights, Illinois Site Public Contact - (ncorp@aah.org)
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois Site Public Contact - (ncorp@aah.org)
Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois Site Public Contact - (ncorp@aah.org)
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Ann M Wierman MD LTD Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Ascension Borgess Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Via Christi - Pittsburg Pittsburg, Kansas Site Public Contact - (jennifer.jameson@ascension.org)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BASS Medical Group - Lennon Walnut Creek, California Site Public Contact - (brenna.lindsey@bassmedicalgroup.com)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Bay Area Tumor Institute Oakland, California
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Borgess Medical Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Boulder Community Foothills Hospital Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer and Blood Specialists-Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Cheyenne Regional Medical Center-West Cheyenne, Wyoming
Chilton Medical Center Pompton, New Jersey
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Colorado Blood Cancer Institute Denver, Colorado
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Freeman Physician Group of Pittsburg Pittsburg, Kansas Site Public Contact - (BNMathew@freemanhealth.com)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Cancer and Blood Disease Treatment Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
GenesisCare USA - Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Las Vegas Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Vegas Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Good Samaritan Regional Health Center Mount Vernon, Illinois
Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan
Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan
Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
HaysMed Hays, Kansas
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (linda.schumacher@mymlc.com)
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (karen.forman@ascension.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Healthcare Port Townsend, Washington
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Las Vegas Prostate Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
MGC Hematology Oncology-Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Wausau Center Wausau, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Neillsville Neillsville, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Modesto, California Site Public Contact - (pallante.beth@mhsil.com)
Mercy Cancer Center-West Lakes Clive, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Paducah Cancer Center Paducah, Kentucky Site Public Contact - (BJWarner@mercy.com)
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Cancer and Blood - Ankeny Ankeny, Iowa
Mission Cancer and Blood - Des Moines Des Moines, Iowa
Mission Cancer and Blood - Laurel Des Moines, Iowa
Mission Cancer and Blood - West Des Moines Clive, Iowa
Mississippi Baptist Medical Center Jackson, Mississippi Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Morristown Medical Center Morristown, New Jersey
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas Site Public Contact - (Emily.Carvell@bmhcc.org)
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newton Medical Center Newton, New Jersey
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
Northwest Wisconsin Cancer Center Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (ewd_research_admin@hshs.org)
Olathe Health Cancer Center Olathe, Kansas Site Public Contact - (atheCCResearch@kumc.edu)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Overlook Hospital Summit, New Jersey
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth Southwest Medical Center Vancouver, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (lkey@peacehealth.org)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina
Prisma Health Cancer Institute - Faris Greenville, South Carolina
Prisma Health Cancer Institute - Greer Greer, South Carolina
Prisma Health Cancer Institute - Seneca Seneca, South Carolina
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Medical Foundation - Santa Rosa Santa Rosa, California
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Queen of The Valley Napa, California
Providence Regional Cancer Partnership Everett, Washington Site Public Contact - (marilyn.birchman@providence.org)
Providence Regional Cancer System-Aberdeen Aberdeen, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Centralia Centralia, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Lacey Lacey, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Shelton Shelton, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Yelm Yelm, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California Site Public Contact - (Najee.Boucher@providence.org)
Providence Saint Mary Regional Cancer Center Walla Walla, Washington Site Public Contact - (Cheryl.Dodd@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Santa Rosa Memorial Hospital Santa Rosa, California
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Radiation Oncology Associates Reno, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverwood Healthcare Center Aitkin, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Rocky Mountain Cancer Centers - Centennial Centennial, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers - Swedish Englewood, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Aurora Aurora, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Boulder Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Littleton Littleton, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado Site Public Contact - (ResearchTracking@Centura.Org)
Rocky Mountain Cancer Centers-Midtown Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Rose Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Thornton Thornton, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rose Medical Center Denver, Colorado
Rush - Copley Medical Center Aurora, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Anthony's Health Alton, Illinois
Saint Charles Health System Bend, Oregon Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Charles Health System-Redmond Redmond, Oregon
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (melissa_beckman@bshsi.org)
Saint Francis Hospital Greenville, South Carolina Site Public Contact - (melissa_beckman@bshsi.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint John Macomb-Oakland Hospital Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri
Saint Louis Cancer and Breast Institute-South City St Louis, Missouri
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Hospital Rhinelander, Wisconsin Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Saint Mary's Regional Medical Center Reno, Nevada
Saint Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Skagit Regional Health Cancer Care Center Mount Vernon, Washington Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org)
Southeast Cancer Center Cape Girardeau, Missouri
Southern Illinois University School of Medicine Springfield, Illinois
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Springfield Clinic Springfield, Illinois
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center Englewood, Colorado
Swedish Medical Center-Ballard Campus Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-Cherry Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The Melanoma and Skin Cancer Institute Englewood, Colorado Site Public Contact - (ryan.weight@theskincancerinstitute.com)
The Women's Imaging Center Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
ThedaCare Cancer Care - Berlin Berlin, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - New London New London, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - Shawano Shawano, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Regional Medical Center Fort Dodge, Iowa
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Unity Hospital Fridley, Minnesota
University Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University Health Truman Medical Center Kansas City, Missouri
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - North Kansas City, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center-Overland Park Overland Park, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Health System Saint Francis Campus Topeka, Kansas
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Nevada at Reno Veterans Affairs Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Valley Radiation Oncology Peru, Illinois
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin Site Public Contact - (ncorp@aurora.org)
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Western Illinois Cancer Treatment Center Galesburg, Illinois

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (CaDAnCe-101)

BeOne Medicines - clinicaltrials@beonemed.com

NCT05006716
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Inclusion Criteria :
• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
• Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
• For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
• Measurable disease by radiographic assessment or serum IgM level (WM only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria:

• Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
• Requires ongoing systemic treatment for any other malignancy
• Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
• Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: BGB-16673
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
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Study Locations

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Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken
American Oncology Partners of Maryland Pa Bethesda, Maryland
Arensia Exploratory Medicine Llc Tbilisi,
Arthur Je Child Comprehensive Cancer Centre Calgary, Alberta
Asan Medical Center Seoul,
Augusta University Augusta, Georgia
Austin Health Heidelberg, Victoria
British Columbia Cancer Agency the Vancouver Centre Vancouver, British Columbia
CHU Henri Mondor Créteil,
Calvary Mater Newcastle Waratah, New South Wales
Cancer Institute Hospital of Jfcr Kotoku, Tokyo
Centre Henri Becquerel Rouen,
Centre Leon Berard Lyon,
Centre de Lutte Contre Le Cancer Institut Bergonie Bordeaux,
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Porto Alegre,
Centroricerche Cliniche Di Verona Srl Verona,
Chiba Cancer Center Chiba, Chiba
Chu Montpellier Hopital Saint Eloi Montpellier,
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) Québec,
Churchill Hospital Oxford University Hospital Nhs Trust Headington,
Columbia University Medical Center New York, New York
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Concord Repatriation General Hospital Concord, New South Wales
Cross Cancer Institute Edmonton, Alberta
Dana Farber Cancer Institute Boston, Massachusetts
Derriford Hospital Plymouth,
Dokuz Eylul University Balçova,
Edinburgh Cancer Centre Edinburgh,
Erciyes University Kayseri,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fred Hutchinson Cancer Research Center Seattle, Washington
Freeman Hospital Newcastle upon Tyne,
Honor Health Research Institute Scottsdale, Arizona
Hopital Claude Huriez Chu Lille Lille,
Hopital Estaing Clermontferrand,
Hopital de la Pitie Salpetriere Paris,
Hospital Alemão Oswaldo Cruz São Paulo,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Erasto Gaertner Curitiba,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Nove de Julho Dasa São Paulo,
Hospital Santa Rita de Cassia Afecc Vitória,
Hospital Sirio Libanes Brasilia Brasília,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda,
Hospital Universitario Vall Dhebron Barcelona,
Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi
Institut Paoli Calmettes Marseille,
Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo,
Istituto Europeo Di Oncologia Milan,
Karmanos Cancer Institute Detroit, Michigan
Karolinska Universitetssjukhuset Solna Stockholm,
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen München,
Klinikum Johannes Gutenberg Universitaet Mainz Mainz,
Linear Clinical Research Nedlands, Western Australia
MD Anderson Cancer Center Houston, Texas
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Mayo Clinic Jacksonville Jacksonville, Florida
Mayo Clinic Phoenix Phoenix, Arizona
Mayo Clinic Rochester Rochester, Minnesota
Md Anderson Cancer Center Madrid Spain Madrid,
Memorial Sloan Kettering Cancer Center MSKCC New York, New York
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida
Niguarda Cancer Center Division of Hematology Milan,
Norton Cancer Institute Pavilion Louisville, Kentucky
Nottingham University Hospitals NHS Trust Nottingham,
Ondokuz Mayis University Samsun,
Ospedale San Raffaele Milan,
Perth Blood Institute West Perth, Western Australia
Peter MacCallum Cancer Centre Melbourne,
Policlinico Sorsola Malpighi, Aou Di Bologna Bologna,
Princess Alexandra Hospital Woolloongabba, Queensland
Princess Margaret Cancer Centre Toronto, Ontario
Pusan National University Hospital Busan,
Real E Benemerita Associacao Portuguesa de Sao Paulo São Paulo,
Roswell Park Comprehensive Cancer Center Buffalo, New York
Sahlgrenska University Hospital Hematology Gothenburg,
Sakarya Training and Research Hospital Sakarya,
Samsung Medical Center Seoul,
Seoul National University Hospital Seoul,
Severance Hospital Yonsei University Health System Seoul,
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo,
Southeastern Regional Medical Center Newnan, Georgia
St Jamess University Hospital Leeds,
St Vincents Hospital Melbourne Fitzroy, Victoria
Stanford Medicine Palo Alto, California
Tampa General Hospital Cancer Institute Tampa, Florida
Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee
Tennessee Oncology, Pllc Nashville Nashville, Tennessee
The Alfred Hospital Melbourne, Victoria
The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi
The Institute of Oncology, Arensia Exploratory Medicine Chisinau,
UCLA Santa Monica Cancer Care Santa Monica, California
Uchealth North Fort Collins, Colorado
Uniklinik Koeln (Aoer) Cologne,
Universitaetsklinikum Schleswig Holstein Campus Luebeck Lübeck,
Universitaetsklinikum Ulm Ulm,
Universitares Krebszentrum Leipzig Leipzig,
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden Dresden,
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of Arizona Cancer Center Tucson, Arizona
University of California San Diego (Ucsd) Moores Cancer Center La Jolla, California
University of Iowa Hospitals and Clinics Iowa City, Iowa
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Weill Cornell Medical College Newyork Presbyterian Hospital New York, New York
Yokohama Municipal Citizens Hospital Yokohama,

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

NCT05206357
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Inclusion Criteria:

• Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
• Disease pathologically confirmed (tumor tissue) by local testing.
• Relapsed or primary refractory disease meeting any of the following criteria:
• Progressive disease at any time during second-line chemoimmunotherapy (CIT).
• Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
• Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
• Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
• Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
• Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
• Recovery from toxic effects of prior chemoimmunotherapy.
• Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
• Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:

• Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
• Other malignancy requiring therapy.
• Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
Drug: Epcoritamab
Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms
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Show 44 locations

Study Locations

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Azienda Ospedaliero Universitaria Meyer /ID# 240049 Florence, Firenze
CHU Bordeaux - Hopital Pellegrin /ID# 240832 Bordeaux,
CHU Sainte-Justine /ID# 240766 Montreal, Quebec
CHU de Nantes, Hotel Dieu -HME /ID# 240831 Nantes, Pays-de-la-Loire
Children's Hospital at Westmead /ID# 240091 Westmead,
Children's Hospital of Philadelphia - Main /ID# 239294 Philadelphia, Pennsylvania
Children's Hospital of Richmond at VCU /ID# 242770 Richmond, Virginia
Cincinnati Childrens Hospital Medical Center /ID# 239823 Cincinnati, Ohio
Dokuz Eylul University Medical Faculty /ID# 239954 Izmir,
Fakultni Nemocnice Brno /ID# 239956 Brno,
Fakultni Nemocnice v Motole /ID# 239957 Praha,
Fondazione IRCCS San Gerardo dei Tintori /ID# 245592 Monza, Monza E Brianza
Hospices Civils de Lyon /ID# 240834 Lyon,
Hospital Infantil Universitario Nino Jesus /ID# 240717 Madrid,
Hospital Universitario Vall d'Hebron /ID# 240715 Barcelona,
Hospital for Sick Children /ID# 240767 Toronto, Ontario
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039 Rome, Lazio
Institut Gustave Roussy /ID# 240966 Villejuif Cedex, Val-de-Marne
Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026 Istanbul,
Kyoto University Hospital /ID# 246907 Kyoto-shi, Kyoto
Levine Children's Hospital /ID# 242765 Charlotte, North Carolina
Lucile Packard Children's Hospitals - Stanford /ID# 240854 Palo Alto, California
NHO Nagoya Medical Center /ID# 246680 Nagoya-shi, Aichi
National Cancer Center Hospital /ID# 246722 Chuo-ku, Tokyo
National Center for Child Health and Development /ID# 246658 Setagaya-ku, Tokyo
National Taiwan University Hospital /ID# 242890 Taipei City,
New York Medical College /ID# 239208 Valhalla, New York
Nicklaus Children's Hospital /ID# 241174 Miami, Florida
Osaka City General Hospital /ID# 246906 Osaka-shi, Osaka
Perth Children's Hospital /ID# 240382 Nedlands, Western Australia
Prinses Maxima Centrum /ID# 239815 Utrecht,
Rambam Health Care Campus /ID# 240037 Haifa,
Royal Children's Hospital /ID# 240384 Parkville, Victoria
Samsung Medical Center /ID# 239895 Seoul,
Schneider Children's Medical Center /ID# 240171 Petah Tikva,
Seoul National University Hospital /ID# 239894 Seoul,
St Jude Children's Research Hospital /ID# 239184 Memphis, Tennessee
The Chaim Sheba Medical Center /ID# 240670 Ramat Gan, Tel-Aviv
Universitaetsklinikum Erlangen /ID# 240861 Erlangen, Bayern
Universitaetsklinikum Giessen und Marburg /ID# 240787 Marburg,
Universitaetsklinikum Muenster /ID# 239970 Muenster, Nordrhein-Westfalen
Universitaetsmedizin Rostock /ID# 240891 Rostock,
Universitair Ziekenhuis Leuven /ID# 242384 Leuven, Vlaams-Brabant
University of Texas Southwestern Medical Center /ID# 240892 Dallas, Texas

Expanded Access of Obinutuzumab in a Patient Who Responded to Treatment While on a Clinical Trial

ctrrecruit@vcu.edu

Yazbeck, Victor, Y
14756
HM20015975
drug: Obinutuzumab, Modality: Chemotherapy (nos)
Non-Hodgkin's Lymphoma
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Virginia Commonwealth University Richmond, Virginia

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Reference Study ID Number: NP30179 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com

Yazbeck, Victor, Y
NCT03075696
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Inclusion Criteria:

• Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [ASCT])
• Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as > 1.0 cm in its longest dimension
• Able to provide a fresh biopsy from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of >/=12 weeks
• AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to ( • Adequate liver, hematological and renal function
• Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
• Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
• Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal (at least 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test
Exclusion Criteria:

• Inability to comply with protocol mandated hospitalizations and restrictions
• Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
• Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
• Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
• Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA4], anti-programmed death 1 [anti-PD1] and anti-programmed death ligand 1 [anti-PDL1]) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
• History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents
• Documented refractoriness to an obinutuzumab-containing regimen
• Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent, including chimeric antigen receptor therapy (CAR-T) within 4 weeks prior to obinutuzumab infusion
• Prior solid organ transplantation
• Prior allogeneic SCT
• Autologous SCT within 100 days prior to obinutuzumab infusion
• Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)
• Current or past history of central nervous system (CNS) lymphoma
• Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed.
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
• Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
• Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
• Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study
• Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to obinutuzumab infusion. Treatment with corticosteroid • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
• History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus, erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Participants with a remote history of, or well controlled autoimmune disease, may be eligible to enroll after consultation with the Medical Monitor
• In Part III DLBCL dexamethasone cohort, patients with a history of hypersensitivity to dexamethasone or systemic corticosteroids will be excluded
Drug: Glofitamab, Drug: Obinutuzumab, Drug: Tocilizumab
Non-Hodgkin's Lymphoma
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A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia Torino, Piemonte
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia Ravenna, Emilia-Romagna
Allegheny Health Network (Pittsburg PA) Pittsburgh, Pennsylvania
Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital, Auckland,
CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte Rennes,
CHU Saint Eloi; Service d'Hématologie Clinique Montpellier,
Cedars Sinai Medical Center Los Angeles, California
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz Warszawa,
Ch Lyon Sud; Hemato Secteur Jules Courmont Pierre Benite,
China Medical University Hospital; Oncology and Hematology Taichung,
Cliniques Universitaires St-Luc Brussels,
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia Milano, Lombardia
Helsinki University Central Hospital; Dept of Oncology Helsinki,
Hopital Claude Huriez; Hematologie Lille,
Hopital Henri Mondor; Hematologie Clinique Creteil,
Hospital Duran i Reynals L'Hospitalet; Hematology Department L'Hospitalet de Llobregat, Barcelona
Hospital Univ. 12 de Octubre; Servicio de Hematologia Madrid,
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia Badalona, Barcelona
Hospital Universitari Vall d'Hebron; Servicio de Hematologia Barcelona,
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia Santander, Cantabria
Hospital del Mar; Servicio de Hematologia Barcelona,
Hunstman Cancer Institute Salt Lake City, Utah
Ingalls Memorial Hospital Harvey, Illinois
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia Rozzano, Lombardia
MSKCC New York, New York
Mount Sinai Medical Center Miami Beach, Florida
National Taiwan Universtiy Hospital; Division of Hematology Taipei,
Peter MacCallum Cancer Centre Melbourne,
Prince of Wales Hospital; Haematology Randwick, New South Wales
Princess Margaret Cancer Center Toronto,
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT København Ø,
Swedish Cancer Inst. Seattle, Washington
Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku Poznań,
UZ Gent Ghent,
University of Kansas Medical Centre Kansas City, Kansas
University of Michigan Ann Arbor, Michigan
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Wrocław,
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz Gdańsk,
Virginia Commonwealth University Medical Center Richmond, Virginia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK Praha 2,
Washington University; Wash Uni. Sch. Of Med Saint Louis, Missouri

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Anne Beaven, MD - anne_beaven@med.unc.edu

NCT05976763
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Inclusion Criteria:
* • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center * Any stage allowed (stage I-IV) * Presence of measurable disease, defined as \>= 1 nodal lesion that is \> 1.5 cm in longest diameter or \>= 1 extranodal lesion that is \> 1 cm in longest diameter * Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days * No prior systemic treatment for mantle cell lymphoma * No prior radiation treatment for stage I MCL * No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody * No prior stem cell transplant * Age \>= 70 years OR age \>= 60 to \< 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \< 45%, b) diffusing capacity for carbon monoxide \< 60% predicted; c) creatinine clearance \< 70 but \> 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \> 6 * ECOG Performance Status 0-2 * Absolute neutrophil count (ANC) \>= 750/mm\^3 (without growth factor support within 7 days) * Platelet count \>= 75,000/mm\^3 (or \>= 50,000/mm\^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days * Creatinine clearance \>= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome) * Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN * Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy * No clinically significant cardiovascular disease including the following * Unstable angina within 3 months before registration * New York Heart Association class III or IV congestive heart failure * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) * QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * No history of stroke or intracranial hemorrhage within 6 months prior to registration * No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills * Potential trial participants should have recovered from major surgery * No vaccination with a live vaccine within 35 days prior to registration * No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment * Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers * Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional
DRUG: Zanubrutinib, BIOLOGICAL: Rituximab, OTHER: Patient Observation, PROCEDURE: Bone Marrow Biopsy, OTHER: Fludeoxyglucose F-18, PROCEDURE: Positron Emission Tomography, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Esophagogastroduodenoscopy, PROCEDURE: Colonoscopy, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration
Mantle Cell Lymphoma
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Alliance for Clinical Trials in Oncology Boston, Massachusetts Anne W. Beaven - (beaven@med.unc.edu)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Cedars Sinai Medical Center Los Angeles, California
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
City of Hope Comprehensive Cancer Center Duarte, California
City of Hope at Irvine Lennar Irvine, California
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dartmouth Cancer Center - North Saint Johnsbury, Vermont Site Public Contact - (cancer.research.nurse@hitchcock.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Emory Johns Creek Hospital Johns Creek, Georgia Site Public Contact - (m.lisa.hwang@emory.edu)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
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Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Freeman Physician Group of Pittsburg Pittsburg, Kansas Site Public Contact - (BNMathew@freemanhealth.com)
Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Grady Health System Atlanta, Georgia
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HaysMed Hays, Kansas
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
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Iowa Methodist Medical Center Des Moines, Iowa
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Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
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Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Mary Greeley Medical Center Ames, Iowa
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McFarland Clinic - Boone Boone, Iowa
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McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
McLaren Cancer Institute-Bay City Bay City, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Central Michigan Mount Pleasant, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Clarkston Clarkston, Michigan Site Public Contact - (ctoadmin@karmanos.org)
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McLaren Cancer Institute-Lapeer Region Lapeer, Michigan Site Public Contact - (ctoadmin@karmanos.org)
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Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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Mercy Hospital Springfield Springfield, Missouri
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Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
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ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rhode Island Hospital Providence, Rhode Island
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Catherine Hospital Garden City, Kansas Site Public Contact - (protocols@AllianceNCTN.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
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Saint Luke's Hospital Chesterfield, Missouri
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
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Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
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Southern Illinois University School of Medicine Springfield, Illinois
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Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

ctrrecruit@vcu.edu

NCT04840602
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Inclusion Criteria:
* Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as determined by IgM protein quantification. * IgM Spike: ≥ 500 mg/dL (≥ 5 g/L) * Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as the lymph nodes or spleen. Note: all participants must have measurable IgM spike, but are not required to have extramedullary disease * Testing to establish baseline disease status must be performed within 28 days prior to registration * Participants must have at least one of the criteria to require therapy for WM including anemia, thrombocytopenia, neuropathy related to WM, symptomatic hyperviscosity or serum viscosity levels greater than 4.0 centipoises, WM associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms. Constitutional symptoms can be described as unintentional weight loss \>= 10% within the previous 6 months prior to screening; Fevers higher than 100.5 degrees Fahrenheit (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without evidence of infection; Night sweats for more than 1 month prior to screening without evidence of infection; Clinically relevant fatigue which is not relieved by rest due to WM * Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug will be excluded from the study. If such participants can be safely switched to an alternative agent, then the participants will be eligible to enroll * Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration * Participants must be \>= 18 years of age * Participants must have history and physical exam within 28 days prior to registration * Participants must have Zubrod performance status =\< 2 * Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration * Total bilirubin =\< 1.5 x IULN (institutional upper limit of the norm) (within 14 days prior to registration) * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x IULN (within 14 days prior to registration) * Alkaline phosphatase =\< 3 x IULN (within 14 days prior to registration) * Platelet count \>= 50,000 cells/mm\^3 (within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration * Hemoglobin \>= 7.5 g/dL (within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration * Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration * Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration * Participants must be able to take and swallow oral medication (capsules) whole. Participants may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * Participants must not be intolerant to rituximab * Participants must not have known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding localized skin and nail bed fungal infections) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) 4 weeks prior to registration * Participants must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). Hepatitis C virus (HCV) testing is only required if clinically indicated or if the participant has a history of HCV * Participants must not consume grapefruit, Seville oranges or starfruit within 3 days prior to the first dose of venetoclax * Participants must not be pregnant or nursing because venetoclax has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], complete abstinence, or sterilized partner) and a barrier method (e.g., condom, cervical ring, sponge, etc.). This also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures throughout the study and for at least 30 days after competition of therapy * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years or watchful waiting is appropriate in the opinion of the treating physician. Also, malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 5 years, is permissible consideration of eligibility for this trial * Participants must be offered the opportunity to participate in specimen banking * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * CROSSOVER CRITERIA: Participants must have been registered and received treatment in the IR or VR arm and must show progression of disease at any time during cycles 3-24 * CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome the participants will not undergo registration step 2 crossover and will be taken off the study * CROSSOVER CRITERIA: Participants must have Zubrod performance status =\< 2 * CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration * CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction on any recent liver function tests within 14 days prior to registration * CROSSOVER CRITERIA: Platelet count \>= 50,000 cells/mm\^3 (without within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration * CROSSOVER CRITERIA: Hemoglobin \>= 7.5 g/dL (without within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration * CROSSOVER CRITERIA: Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (without within 14 days prior to registration) * NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Ibrutinib, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Rituximab, DRUG: Venetoclax
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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Study Locations

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Adena Regional Medical Center Chillicothe, Ohio
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Columbus Oncology and Hematology Associates Inc Columbus, Ohio
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio
Doctors Hospital Columbus, Ohio
Dublin Methodist Hospital Dublin, Ohio
Fairfield Medical Center Lancaster, Ohio
Genesee Hematology Oncology PC Flint, Michigan
Genesis Healthcare System Cancer Care Center Zanesville, Ohio
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Glens Falls Hospital Glens Falls, New York
Grady Memorial Hospital Delaware, Ohio
Grant Medical Center Columbus, Ohio
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Knox Community Hospital Mount Vernon, Ohio
Levine Cancer Institute-Gaston Gastonia, North Carolina
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marietta Memorial Hospital Marietta, Ohio
Marshfield Medical Center - Minocqua Minocqua, Wisconsin
Marshfield Medical Center - Weston Weston, Wisconsin
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Health - Perrysburg Hospital Perrysburg, Ohio
Mercy Health - Saint Anne Hospital Toledo, Ohio
Mercy Health - Saint Vincent Hospital Toledo, Ohio
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Mount Carmel East Hospital Columbus, Ohio
Mount Carmel Grove City Hospital Grove City, Ohio
Mount Carmel Health Center West Columbus, Ohio
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
Newark Radiation Oncology Newark, Ohio
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
OhioHealth Mansfield Hospital Mansfield, Ohio
OhioHealth Marion General Hospital Marion, Ohio
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Riverside Methodist Hospital Columbus, Ohio
Saint Ann's Hospital Westerville, Ohio
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Rita's Medical Center Lima, Ohio
Saint Vincent Frontier Cancer Center Billings, Montana
Siteman Cancer Center at Christian Hospital St Louis, Missouri
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri
Siteman Cancer Center-South County St Louis, Missouri
Southeastern Medical Oncology Center-Clinton Clinton, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ohio Medical Center Portsmouth, Ohio
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Strecker Cancer Center-Belpre Belpre, Ohio
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The Mark H Zangmeister Center Columbus, Ohio
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
University of Rochester Rochester, New York
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Washington University School of Medicine St Louis, Missouri

Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

Hall, Charles, E. - hallce3@vcu.edu

Simmons, Gary, L.
NCT04400591
HM20022052
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Inclusion Criteria:

• Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
• Subject has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information.
• Subject is ? 18 years of age at the time of signing the informed consent form.
• Subject had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria.
• Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
• Subject is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy.
• Females of childbearing potential must:
• Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration.
• Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
• Male subjects must:
• Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the subject has undergone a successful vasectomy.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician
• Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration.
Exclusion Criteria:

• Subject has a hypersensitivity to the active substance or to any of the excipients.
• Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.
• Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
• Pregnant or nursing women or has intention of becoming pregnant during the study.
• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study).
• Subject has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation
• Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration.
• Subject has presence of acute or chronic graft-versus-host disease (ie, GVHD)
• Use of the following:
• Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted.
• Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ? 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting chemotherapy.
• Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy.
• Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.
Biological: Nonconforming Lisocabtagene Maraleucel
Lymphoma, Large B-Cell, Diffuse
Expanded Access, JCAR017, Lisocabtagene Maraleucel, CAR T, nonconforming,, relapsed/refractory diffuse large B cell lymphoma, nonconforming lisocabtagene mareleucel
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Show 76 locations

Study Locations

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Allegheny Health Network Pittsburgh, Pennsylvania
Avera Cancer Institute Sioux Falls, South Dakota
Baylor University Medical Center Dallas, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Cancer Center Of Kansas Wichita, Kansas
Cancer Centre of Excellence - Univ of MA Medical School Worcester, Massachusetts
Cancer Treatment Centers of America, Chicago Zion, Illinois
Cedars-Sinai Medical Center Los Angeles, California
Chiba University Hospital Chiba, Chiba
City of Hope Duarte, California
Cleveland Clinic - Taussig Cancer Institute Cleveland, Ohio
Colorado Blood Cancer Institute Denver, Colorado
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fred Hutchinson Cancer Research Center Seattle, Washington
Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin
Georgetown University Hospital Washington, District of Columbia
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health System Division of Hematology Oncology Detroit, Michigan
Hokkaido University Hospital Sapporo, Hokkaido
HonorHealth Research Institute Scottsdale, Arizona
Houston Methodist Hospital Houston, Texas
Hyogo College of Medicine Hospital Hyōgo,
Intermountain Healthcare - LDS Hospital Salt Lake City, Utah
Jichi Medical University Hospital Shimotsuge-shi, Tochigi
Kanazawa University Hospital Kanazawa,
Karmanos Cancer Institute Detroit, Michigan
Keio University Hospital Tokyo,
Kindai University Hospital Sakai,
Kumamoto University Hospital Kumamoto,
Kyoto University Hospital Kyoto,
Kyushu University Hospital Fukuoka,
Levine Cancer Institute Charlotte, North Carolina
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida
Mayo Clinic Cancer Center Jacksonville, Florida
Medical City Dallas Hospital Dallas, Texas
Memorial Sloan Kettering Cancer Center New York, New York
Methodist Hospital - Texas Transplant Institute San Antonio, Texas
Moffit Cancer Center Tampa, Florida
Mount Sinai Hospital New York, New York
National Cancer Center Hospital Tokyo,
New York Oncology Hematology P.C. Albany, New York
New York Presbyterian Hospital Weill Medical College Cornell University New York, New York
Northwestern University Medical Center Chicago, Illinois
Okayama University Hospital Okayama,
Oregon Health and Science University Portland, Oregon
Osaka City University Hospital Osaka,
Osaka University Hospital OUH Osaka-Fu,
Prisma Health System - Eastside Cancer Center Greenville, South Carolina
Roswell Park Cancer Center Buffalo, New York
Rush University Medical Center Chicago, Illinois
Sarah Cannon Research Institute Nashville, Tennessee
Spectrum Health Grand Rapids, Michigan
Swedish Cancer Institute Seattle, Washington
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
The University of Texas - MD Anderson Cancer Center Houston, Texas
Tohoku University Hospital Sendai,
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo,
UT Southwestern Medical Center Dallas, Texas
University Hospitals Case Medical Center Cleveland, Ohio
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of California San Francisco Medical Center San Francisco, California
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Aurora, Colorado
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina Chapel Hill, North Carolina
University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City, Oklahoma
University of Pittsburgh Medical Center Hillman Cancer Center Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
VCU Massey Cancer Center Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia Hall, Charles, E. - (hallce3@vcu.edu)
West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia
Winship Cancer Institute of Emory University Atlanta, Georgia
Yale University School of Medicine New Haven, Connecticut

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

ctrrecruit@vcu.edu

NCT04269902
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Inclusion Criteria:
* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration * Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities) * Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p * TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p) * Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed * Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration) * Serum beta-2 microglobulin level must be obtained within 28 days prior to registration * Participants must not meet any of the IWCLL specified criteria for active CLL therapy * Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment * Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration * Prior therapy with anti CD20 monoclonal antibodies is not allowed * Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of COVID-19), or radiotherapy * Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy * Participants must be \>= 18 years of age * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Platelet count \>= 100,000/mm\^3 within 28 days prior to registration * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration * Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration * Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration * Participants must be able to take oral medications * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy * Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor * Participants must not have cirrhosis * Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O. * Active infection with hepatitis B or C: * Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR). * Latent infection with hepatitis B: * Latent infection is defined as meeting all of the following criteria: * Hepatitis B surface antigen positive * Anti-hepatitis B total core antibody positive * Anti-hepatitis IgM core antibody undetectable * Hepatitis B PCR undetectable * Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O. * Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis * Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair * Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia) * Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment * Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5 * Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura * Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification * Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment * Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Participants must agree to have specimens submitted for translational medicine (MRD) as outlined * Participants must be offered the opportunity to participate in specimen banking for future research as outlined. * NOTE: With participant's consent, the site must follow through with specimen submission as outlined * Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.) * Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Obinutuzumab, OTHER: Questionnaire Administration, DRUG: Venetoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota
Adena Regional Medical Center Chillicothe, Ohio
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Alaska Breast Care and Surgery LLC Anchorage, Alaska
Alaska Oncology and Hematology LLC Anchorage, Alaska
Alaska Women's Cancer Care Anchorage, Alaska
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska
Alegent Health Immanuel Medical Center Omaha, Nebraska
Alegent Health Lakeside Hospital Omaha, Nebraska
Alegent Health Mercy Hospital Council Bluffs, Iowa
Allan Blair Cancer Centre Regina, Saskatchewan
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Armes Family Cancer Center Findlay, Ohio
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin
Aspirus Regional Cancer Center Wausau, Wisconsin
Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio
BCCA-Vancouver Cancer Centre Vancouver, British Columbia
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Ballad Health Cancer Care - Bristol Bristol, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Norton Norton, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Banner McKee Medical Center Loveland, Colorado
Banner North Colorado Medical Center Greeley, Colorado
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Hospital Coos Bay, Oregon
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Beebe Health Campus Rehoboth Beach, Delaware Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware
Beebe South Coastal Health Campus Millville, Delaware Site Public Contact - (research@beebehealthcare.org)
Bellin Memorial Hospital Green Bay, Wisconsin
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming
Blanchard Valley Hospital Findlay, Ohio
Boulder Community Foothills Hospital Boulder, Colorado
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bristol Regional Medical Center Bristol, Tennessee
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CHI Health Good Samaritan Kearney, Nebraska
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
Cambridge Medical Center Cambridge, Minnesota
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona
Cancer Center of Colorado at Sloan's Lake Denver, Colorado
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer Partners of Nebraska Lincoln, Nebraska
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan
Central Care Cancer Center - Bolivar Bolivar, Missouri
Central Care Cancer Center - Garden City Garden City, Kansas
Central Care Cancer Center - Great Bend Great Bend, Kansas
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio
Centralia Oncology Clinic Centralia, Illinois
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Cheyenne Regional Medical Center-West Cheyenne, Wyoming
Christiana Care Health System-Christiana Hospital Newark, Delaware
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware
City of Hope Antelope Valley Lancaster, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Newport Beach Newport Beach, California
City of Hope Seacliff Huntington Beach, California
City of Hope South Bay Torrance, California
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
City of Hope at Long Beach Elm Long Beach, California
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Mercy Hospital Canton, Ohio
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Colorado Blood Cancer Institute Denver, Colorado
Columbus Oncology and Hematology Associates Inc Columbus, Ohio
CommonSpirit Cancer Center Mercy Durango, Colorado
Commonwealth Cancer Center-Corbin Corbin, Kentucky
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Dayton Physicians LLC-Wayne Greenville, Ohio
Decatur Memorial Hospital Decatur, Illinois
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio
Doctors Hospital Columbus, Ohio
Dublin Methodist Hospital Dublin, Ohio
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Durham VA Medical Center Durham, North Carolina
ECU Health Oncology Kenansville Kenansville, North Carolina
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
FHCC Overlake Bellevue, Washington
FHCC at EvergreenHealth Kirkland, Washington
FHCC at Northwest Hospital Seattle, Washington
Fairbanks Memorial Hospital Fairbanks, Alaska
Fairfield Medical Center Lancaster, Ohio
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota
Fairview Lakes Medical Center Wyoming, Minnesota
Fairview Northland Medical Center Princeton, Minnesota
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota
Flaget Memorial Hospital Bardstown, Kentucky
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Fred Hutchinson Cancer Center Seattle, Washington
Freeman Health System Joplin, Missouri
Fremont - Rideout Cancer Center Marysville, California
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio
Grady Memorial Hospital Delaware, Ohio
Grand Valley Oncology Grand Junction, Colorado Site Public Contact - (gvoclinicaltrials@gjhosp.org)
Grant Medical Center Columbus, Ohio
Great Falls Clinic Great Falls, Montana
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa
Gundersen Lutheran Medical Center La Crosse, Wisconsin
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
Harold Alfond Center for Cancer Care Augusta, Maine
Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington
HaysMed Hays, Kansas
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-Auburn Auburn, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hematology/Oncology Clinic PLLC Baton Rouge, Louisiana
Hennepin County Medical Center Minneapolis, Minnesota
Henry Ford Cancer Institute-Downriver Brownstown, Michigan
Henry Ford Health Providence Southfield Hospital Southfield, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Health Center - Shelby Township Shelby, Michigan
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Fairlane Dearborn, Michigan
Henry Ford River District Hospital East China Township, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan
Henry Ford Warren Hospital - GLCMS Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Hickman Cancer Center Adrian, Michigan
Highline Medical Center-Main Campus Burien, Washington
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan
Hope Cancer Clinic Livonia, Michigan
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Idaho Urologic Institute-Meridian Meridian, Idaho
Illinois CancerCare - Washington Washington, Illinois
Illinois CancerCare-Bloomington Bloomington, Illinois
Illinois CancerCare-Canton Canton, Illinois
Illinois CancerCare-Carthage Carthage, Illinois
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois
Illinois CancerCare-Galesburg Galesburg, Illinois
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois
Illinois CancerCare-Macomb Macomb, Illinois
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois
Illinois CancerCare-Pekin Pekin, Illinois
Illinois CancerCare-Peoria Peoria, Illinois
Illinois CancerCare-Peru Peru, Illinois
Illinois CancerCare-Princeton Princeton, Illinois
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Healthcare Port Townsend, Washington
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Jersey City Medical Center Jersey City, New Jersey
Jewish General Hospital Montreal, Quebec
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Katmai Oncology Group Anchorage, Alaska
Kettering Medical Center Kettering, Ohio
Knox Community Hospital Mount Vernon, Ohio
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana
Lakeridge Health Oshawa Oshawa, Ontario
Lakeview Hospital Stillwater, Minnesota
Langlade Hospital and Cancer Center Antigo, Wisconsin
Lawrence Memorial Hospital Lawrence, Kansas
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Longmont United Hospital Longmont, Colorado
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshall Cancer Center Cameron Park, California Site Public Contact - (cancerservices@marshallmedical.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital Chattanooga, Tennessee Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital of Carbondale Carbondale, Illinois
Memorial Medical Center-Las Cruces Las Cruces, New Mexico Site Public Contact - (Deborah.Brown@LPNT.net)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California
Mercy Cancer Center - Elk Grove Elk Grove, California
Mercy Cancer Center - Rocklin Rocklin, California
Mercy Cancer Center - Sacramento Sacramento, California
Mercy Cancer Center-West Lakes Clive, Iowa
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Perrysburg Hospital Perrysburg, Ohio
Mercy Health - Saint Anne Hospital Toledo, Ohio
Mercy Health - Saint Vincent Hospital Toledo, Ohio
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Medical Center Durango, Colorado
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California
Methodist Medical Center of Illinois Peoria, Illinois
Methodist West Hospital West Des Moines, Iowa
Miami Valley Hospital Dayton, Ohio
Miami Valley Hospital North Dayton, Ohio
Miami Valley Hospital South Centerville, Ohio
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Mid Coast Hospital Brunswick, Maine Site Public Contact - (ctsucontact@westat.com)
Midlands Community Hospital Papillion, Nebraska
Minneapolis VA Medical Center Minneapolis, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California
Mission Hope Medical Oncology - Santa Maria Santa Maria, California
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monmouth Medical Center Southern Campus Lakewood, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monticello Cancer Center Monticello, Minnesota
Mount Carmel East Hospital Columbus, Ohio
Mount Carmel Grove City Hospital Grove City, Ohio
Mount Carmel Health Center West Columbus, Ohio
Mount Sinai Hospital New York, New York
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
National Jewish Health-Main Campus Denver, Colorado
National Jewish Health-Northern Hematology Oncology Thornton, Colorado
National Jewish Health-Western Hematology Oncology Golden, Colorado
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
New Ulm Medical Center New Ulm, Minnesota
Newark Radiation Oncology Newark, Ohio
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
North Memorial Medical Health Center Robbinsdale, Minnesota
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwest Medical Specialties PLLC Tacoma, Washington
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Anthony's Health Center Alton, Illinois
Ochsner LSU Health Monroe Medical Center Monroe, Louisiana
Ochsner LSU Health Saint Mary's Medical Center Shreveport, Louisiana
Ohio State University Comprehensive Cancer Center Columbus, Ohio
OhioHealth Mansfield Hospital Mansfield, Ohio
OhioHealth Marion General Hospital Marion, Ohio
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Orion Cancer Care Findlay, Ohio
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California
Pacific Gynecology Specialists Seattle, Washington
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint John Medical Center Longview, Washington
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth Southwest Medical Center Vancouver, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth United General Medical Center Sedro-Woolley, Washington
Penrose-Saint Francis Healthcare Colorado Springs, Colorado
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Physicians' Clinic of Iowa PC Cedar Rapids, Iowa
Pocono Medical Center East Stroudsburg, Pennsylvania
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado
Presbyterian Kaseman Hospital Albuquerque, New Mexico
Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico Site Public Contact - (WBurman@phs.org)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Regional Cancer Partnership Everett, Washington
Providence Regional Cancer System-Aberdeen Aberdeen, Washington
Providence Regional Cancer System-Centralia Centralia, Washington
Providence Regional Cancer System-Lacey Lacey, Washington
Providence Regional Cancer System-Shelton Shelton, Washington
Providence Regional Cancer System-Yelm Yelm, Washington
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California
Providence Saint Mary Regional Cancer Center Walla Walla, Washington
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A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Toll Free Number - Trialsites@msd.com

NCT06136559
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy. * Has at least 1 marker of disease burden. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization. * Has the ability to swallow and retain oral medication. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening. * Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection. * Has gastrointestinal (GI) dysfunction that may affect drug absorption. * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL. * Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening. * Has clinically significant cardiovascular disease. * Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients. * Has history of severe bleeding disorder. * Has known additional malignancy that is progressing or has required active treatment within the past 2 years. * Has received any systemic anticancer therapy for CLL/SLL. * Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors. * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration. * Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
DRUG: Nemtabrutinib, DRUG: Ibrutinib, DRUG: Acalabrutinib
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Study Locations

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Location Contacts
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205) Mechelen, Antwerpen
Aalborg Universitetshospital, Syd ( Site 0403) Aalborg, North Denmark
Akershus Universitetssykehus ( Site 0902) Lørenskog, Akershus
Alta Bates Summit Medical Center ( Site 0004) Berkeley, California
Anhui Provincial Cancer Hospital ( Site 2001) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407) Ankara,
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401) Ankara,
Antalya Egitim ve Arastırma Hastanesi ( Site 1409) Antalya,
Aotearoa Clinical Trials ( Site 3201) Auckland,
Arizona Oncology Associates - NAHOA ( Site 8007) Prescott, Arizona
BC Cancer Kelowna ( Site 0112) Kelowna, British Columbia
BC Cancer Victoria ( Site 0109) Victoria, British Columbia
Barnet Hospital ( Site 3005) Barnet,
Bnai Zion Medical Center ( Site 1505) Haifa,
Bradfordhill-Clinical Area ( Site 2310) Santiago, Region M. de Santiago
Cancer Care Associates Of York ( Site 0005) York, Pennsylvania
Cancer Institute Hospital of JFCR ( Site 1906) Koto, Tokyo
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100) Rimouski, Quebec
Centro Medico Monte Carmelo-Oncology ( Site 2706) Arequipa, Ariqipa
Centro de Infusion Superare ( Site 2602) Mexico City, Mexico City
Champalimaud Foundation ( Site 3102) Lisbon, Lisbon District
Chang Gung Medical Foundation-Linkou Branch ( Site 1703) Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702) Kaohsiung City,
Chiba Cancer Center ( Site 1905) Chiba,
Chongqing University Cancer Hospital ( Site 2041) Chongqing, Chongqing Municipality
Chulalongkorn University ( Site 1802) Bangkok, Bangkok
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003) Nottingham,
Clermont Oncology Center ( Site 0046) Clermont, Florida
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306) Santiago, Region M. de Santiago
Clínica Anglo Americana ( Site 2701) Lima,
Constantiaberg Haematology ( Site 1106) Plumstead, Western Cape
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall, Pennsylvania
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids, Michigan
Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich, Connecticut
Ege Universitesi Hastanesi ( Site 1404) Izmir,
Evangelismos General Hospital of Athens ( Site 0700) Athens, Attica
FALP-UIDO ( Site 2300) Santiago, Region M. de Santiago
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801) Bangkok, Bangkok
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301) Hradec Králové,
Fakultni nemocnice Olomouc ( Site 0303) Olomouc,
Florida Cancer Specialists - East ( Site 7002) West Palm Beach, Florida
Florida Cancer Specialists - South ( Site 7001) Fort Myers, Florida
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402) Cali, Valle del Cauca Department
Galilee Medical Center ( Site 1507) Nahariya,
General Hospital of Athens "Laiko" ( Site 0704) Athens, Attica
GenesisCare - Bristol ( Site 3011) Bristol, South Gloucestershire
GenesisCare - Cambridge ( Site 3001) Newmarket, Suffolk
GenesisCare - Windsor ( Site 3002) Windsor, Windsor And Maidenhead
Groote Schuur Hospital-Clinical Haematology ( Site 1100) Cape Town, Western Cape
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) Nanning, Guangxi
Gunma University Hospital ( Site 1903) Maebashi, Gunma
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202) Barcelona, Catalonia
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208) Majadahonda, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209) Pozuelo de Alarcón, Madrid
Hadassah Medical Center-Hemato-Oncology ( Site 1500) Jerusalem,
Haemalife ( Site 1105) Kuilsriver, Western Cape
Hainan General Hospital ( Site 2018) Haikou, Hainan
Health Pharma Professional Research S.A. de C.V: ( Site 2608) Mexico City, Mexico City
Henan Cancer Hospital-hematology department ( Site 2025) Zhengzhou, Henan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913) Hiroshima,
Hokkaido University Hospital ( Site 1900) Sapporo, Hokkaido
Hospital 9 De Julho ( Site 2206) São Paulo, São Paulo
Hospital Paulistano-Americas Oncologia ( Site 2202) São Paulo,
Hospital Pulau Pinang ( Site 1602) George Town, Pulau Pinang
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206) Barcelona,
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201) Salamanca,
Hunan Cancer Hospital ( Site 2020) Changsha, Hunan
IMAT S.A.S ( Site 2401) Montería, Departamento de Córdoba
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606) Koblenz, Rhineland-Palatinate
Inova Schar Cancer Institute ( Site 0015) Fairfax, Virginia
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207) L'Hospitalet Del Llobregat, Barcelona
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005) Tianjin, Tianjin Municipality
Instituto Nacional de Câncer - INCA ( Site 2201) Rio de Janeiro,
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103) Lisbon, Lisbon District
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100) Porto,
Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction, Colorado
Japanese Red Cross Osaka Hospital ( Site 1908) Osaka,
Jiangsu Province Hospital ( Site 2000) Nanjing, Jiangsu
Jiangxi Provincial Cancer Hospital ( Site 2009) Nanchang, Jiangxi
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack, New Jersey
Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County
Kindai University Hospital ( Site 1909) Sayama, Osaka
Kliniken Maria Hilf ( Site 0603) Mönchengladbach, North Rhine-Westphalia
Kobe City Medical Center General Hospital ( Site 1910) Kobe, Hyōgo
Kyushu University Hospital ( Site 1914) Fukuoka,
Liuzhou People's Hospital ( Site 2029) Liuzhou, Guangxi
Lutheran Medical Center ( Site 0027) Golden, Colorado
Maharaj Nakorn Chiang Mai Hospital ( Site 1800) Muang, Chiang Mai
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408) Istanbul,
McGill University Health Centre ( Site 0106) Montreal, Quebec
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010) Spokane, Washington
Mega Medipol ( Site 1412) Istanbul,
MidAmerica Cancer Care, LLC ( Site 0043) Kansas City, Missouri
Moores Cancer Center ( Site 0003) La Jolla, California
Nagoya University Hospital ( Site 1907) Nagoya, Aichi-ken
Naresuan University Hospital ( Site 1804) Muang, Changwat Phitsanulok
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004) Warsaw, Masovian Voivodeship
National Cheng Kung University Hospital ( Site 1700) Tainan,
National Taiwan University Hospital ( Site 1701) Taipei,
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101) Pretoria, Gauteng
North Shore Hospital-Department of Haematology ( Site 3200) Auckland,
Odense Universitetshospital-Department of Hematology ( Site 0401) Odense C, Region Syddanmark
Okayama University Hospital ( Site 1912) Okayama,
Oncology Specialists of Charlotte ( Site 0054) Charlotte, North Carolina
Ondokuz Mays Üniversitesi ( Site 1410) Samsun,
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600) Berlin,
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901) Oslo,
Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne, Indiana
Peking University First Hospital ( Site 2022) Beijing, Beijing Municipality
Peking University Third Hospital-Hematology ( Site 2011) Beijing, Beijing Municipality
Pratia MCM Krakow ( Site 1007) Krakow, Lesser Poland Voivodeship
Pratia Onkologia Katowice ( Site 1009) Katowice, Silesian Voivodeship
Queen Elizabeth Hospital ( Site 1603) Kota Kinabalu, Sabah
Queen Mary Hospital ( Site 3300) Hong Kong,
Rabin Medical Center ( Site 1504) Petah Tikva,
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503) Haifa,
Regions Hospital ( Site 0042) Saint Louis Park, Minnesota
Roskilde Sygehus-Department of Hematology ( Site 0402) Roskilde, Region Sjælland
Roswell Park Cancer Institute ( Site 0023) Buffalo, New York
Royal Lancaster Infirmary ( Site 3012) Lancaster, Lancashire
Royal North Shore Hospital ( Site 2806) St Leonards, New South Wales
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048) Madison, Wisconsin
Saint Elizabeth Healthcare ( Site 0041) Edgewood, Kentucky
Saint Joseph Hospital ( Site 0026) Denver, Colorado
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005) Olsztyn, Warmian-Masurian Voivodeship
Shaanxi provincial people's hospital ( Site 2012) Xi'an, Shaanxi
Shandong Cancer Hospital ( Site 2003) Jinan, Shandong
Shanxi Cancer Hospital ( Site 2033) Taiyuan, Shanxi
Sheba Medical Center-Hemato Oncology ( Site 1501) Ramat Gan,
Shimane University Hospital ( Site 1911) Izumo, Shimane
Sisli Florence Nightingale Hastanesi ( Site 1411) Istanbul,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405) Valledupar, Cesar Department
Songklanagarind hospital ( Site 1803) Hat Yai, Changwat Songkhla
Southeastern Medical Oncology Center ( Site 0049) Goldsboro, North Carolina
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) Guangzhou, Guangdong
Southmead Hospital ( Site 3010) Bristol, Bristol, City of
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006) London, London, City of
St James's University Hospital ( Site 3004) Leeds,
Summit Medical Group Cancer Center ( Site 0007) Florham Park, New Jersey
Sun Yat-sen University Cancer Center ( Site 2028) Guangzhou, Guangdong
Sykehuset i Vestfold ( Site 0903) Tønsberg, Vestfold
TENNESSEE ONCOLOGY ( Site 0031) Nashville, Tennessee
Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga, Tennessee
Texas Oncology - Central/South Texas ( Site 8008) Austin, Texas
Texas Oncology - Northeast Texas ( Site 8012) Tyler, Texas
Texas Oncology - San Antonio ( Site 8006) San Antonio, Texas
The Affiliated Hospital of Guizhou Medical University ( Site 2024) Guiyang, Guizhou
The Affiliated Hospital of Xuzhou Medical College ( Site 2013) Xuzhou, Jiangsu
The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth, Texas
The Churchill Hospital ( Site 3007) Oxford, Oxfordshire
The First Affiliated Hospital of Nanchang University ( Site 2023) Nanchang, Jiangxi
The First Affliated Hospital of Suzhou University ( Site 2027) Suzhou, Jiangsu
The First Hospital of Jilin University-Hematology ( Site 2030) Changchun, Jilin
The Ottawa Hospital - General Campus ( Site 0102) Ottawa, Ontario
The Second Xiangya Hospital of Central South University ( Site 2010) Changsha, Hunan
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002) Hangzhou, Zhejiang
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019) Tianjin, Tianjin Municipality
Tohoku University Hospital ( Site 1901) Sendai, Miyagi
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016) Wuhan, Hubei
Trakya University-Balkan Onkoloji Hastanesi ( Site 1403) Edirne,
USA Mitchell Cancer Institute ( Site 0014) Mobile, Alabama
UZ Leuven-Hematology ( Site 0200) Leuven, Vlaams-Brabant
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107) Vila Nova de Gaia, Porto District
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104) Lisbon,
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106) Lisbon,
Universitaetsklinikum Ulm. ( Site 0601) Ulm, Baden-Wurttemberg
University Hospital and UW Health Clinics ( Site 0006) Madison, Wisconsin
University Hospital of Alexandroupolis ( Site 0701) Alexandroupoli, East Macedonia and Thrace
University Hospital of Ioannina ( Site 0702) Ioannina,
University Malaya Medical Centre ( Site 1604) Lembah Pantai, Kuala Lumpur
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017) Iowa City, Iowa
University of Virginia Cancer Center ( Site 0040) Charlottesville, Virginia
Universitätsklinikum Halle ( Site 0604) Halle, Saxony-Anhalt
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006) Lublin, Lublin Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011) Gdansk, Pomeranian Voivodeship
VK&K Studien GbR ( Site 0607) Landshut, Bavaria
Virginia Commonwealth University (VCU) Medical Center ( Site 0030) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) Prague,
Waikato Hospital-Haematology ( Site 3202) Hamilton, Waikato Region
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026) Chengdu, Sichuan
William Osler Health System ( Site 0103) Brampton, Ontario
Wits Clinical Research ( Site 1102) Johannesburg, Gauteng
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013) Słupsk, Pomeranian Voivodeship
Wuhan Union Hospital ( Site 2015) Wuhan, Hebei
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014) Ürümqi, Xinjiang
Yamagata University Hospital ( Site 1902) Yamagata,
Yitzhak Shamir Medical Center. ( Site 1506) Ẕerifin,
Zhejiang Cancer Hospital ( Site 2017) Hangzhou, Zhejiang
hospital universitario de canarias ( Site 1205) San Cristóbal de La Laguna, Santa Cruz De Tenerife

Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

ctrrecruit@vcu.edu

NCT05602194
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis * Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL) * Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used) * Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and * Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline * SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline * For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days * PEDIATRIC PATIENTS (AGE 15-17 years): * A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR * A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment): * 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2. * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped * 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard). * ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc * Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and * First dose of asparaginase must be planned within the first week of induction therapy, and * Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen) * Note: Co-enrollment on a therapeutic consortia trial is not required * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Down syndrome * Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other) * Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3) * Unable to tolerate oral formulation of study drug at enrollment * Patients who received chemotherapy or treatment for a prior malignancy are not eligible * The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented * Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
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Study Locations

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AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Ann M Wierman MD LTD Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
C S Mott Children's Hospital Ann Arbor, Michigan
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital at Montefiore The Bronx, New York Site Public Contact - (aaraiza@montefiore.org)
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
East Tennessee Childrens Hospital Knoxville, Tennessee
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
GenesisCare USA - Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Las Vegas Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Hackensack University Medical Center Hackensack, New Jersey
Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
Hospital for Sick Children Toronto, Ontario
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Diego Mission San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Loma Linda University Medical Center Loma Linda, California
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Miami Cancer Institute Miami, Florida
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Penn State Children's Hospital Hershey, Pennsylvania
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Greenville Memorial Hospital Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Radiation Oncology Associates Reno, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Sacred Heart Hospital Pensacola, Florida
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UMC Cancer Center / UMC Health System Lubbock, Texas
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin Site Public Contact - (ncorp@aurora.org)
Wake Forest University Health Sciences Winston-Salem, North Carolina
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)

Improving Exercise Capacity With a Tailored Physical Activity Intervention (PALS)

Study Coordinator - kristin.johnson@advocatehealth.org

NCT05595577
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Inclusion Criteria:
To be considered eligible, participants must meet all of the following criteria: * Individuals aged 18- 85 years * Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer * Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzumab, rituximab\]), immuno-therapies (immune checkpoint inhibitors \[ICI's\]) or radiation (within 8 weeks of completion of radiation).29-31 * Ability to speak and understand English * Capacity to walk at least 2 city blocks (\~.2 miles) on a flat surface * Expected survival beyond 6 months. * Must have an assistant that will help perform the home-based testing activities
Exclusion Criteria:
If the patient meets any of these criteria they are excluded from the study: * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg) * Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved. * Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator) * Pregnant * Unstable angina * Contraindication for exercise training or testing * Inability to exercise on a treadmill or stationary cycle * Significant ventricular arrhythmias (\>20 PVCs/min due to gating difficulty) * Atrial fibrillation with uncontrolled ventricular response * Acute myocardial infarction within 28 days * Inability to provide informed consent
OTHER: Exercise with Trainerize application, DIAGNOSTIC_TEST: Cardiopulmonary exercise testing, DIAGNOSTIC_TEST: MRI scan, BEHAVIORAL: Quality of Life Questionnaires, BEHAVIORAL: Cognitive and Brain Function Questionnaires, OTHER: Blood draws
Non Hodgkin Lymphoma, Heart, Functional Disturbance, Hodgkin Lymphoma, Quality of Life, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Exercise capability, Brain activity
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Study Locations

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Location Contacts
Virginia Commonwealth University Richmond, Virginia
Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Study Director - clinicaltrials@beonemed.com

NCT05952037
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Inclusion Criteria:
* Clinical and definitive histologic diagnosis of WM. * Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM). * For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy. * For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis). * Adequate organ function.
Exclusion Criteria:
* Central nervous system (CNS) involvement by WM. * Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma. * History of other malignancies ≤ 2 years before study entry. * Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Sonrotoclax, DRUG: Zanubrutinib
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Waldenström's macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory, Lymphoma, BGB-11417, BCL-2i
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Study Locations

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Affiliated Zhongshan Hospital of Fudan University Shanghai, Shanghai Municipality
Atrium Health Levine Cancer Institute (Lci) Charlotte, North Carolina
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del Udine,
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Brescia,
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan,
Beatson West of Scotland Cancer Centre Glasgow,
Centre Hospitalier Universitaire Damiens Hopital Sud Amiens,
Chu Clermont Ferrand Therapie Cellulaire and Hematolo Clermontferrand,
Chu Hopital Lyon Sud PierreBenite,
Churchill Hospital Oxford University Hospital Nhs Trust Headington,
City of Hope National Medical Center Duarte, California
Colorado Blood Cancer Institute Denver, Colorado
Concord Repatriation General Hospital Concord, New South Wales
Cross Cancer Institute Edmonton, Alberta
Dana Farber Cancer Institute Boston, Massachusetts
Flinders Medical Centre Bedford Park,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
General Hospital of Athens Alexandra Athens,
GenesisCare North Shore St Leonards, New South Wales
Guangdong Provincial Peoples Hospital Guangzhou, Guangdong
Hattiesburg Hematology and Oncology Clinic Hattiesburg, Mississippi
Henan Cancer Hospital Zhengzhou,
Hopital Robert Debre Reims,
Hopital de la Pitie Salpetriere Paris,
Hospital Clinic de Barcelona Barcelona,
Hospital Universitari Mutua Terrassa Terrassa,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario Vall Dhebron Barcelona,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Salamanca Salamanca,
Huntsman Cancer Institute Salt Lake City, Utah
Institut Catala Doncologia Barcelona,
Institut Paoli Calmettes Marseille,
Institute of Hematology and Hospital of Blood Disease Tianjin, Tianjin Municipality
Irccs Azienda Ospedaliero Universitaria Bologna Bologna,
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi Pavia,
Istituto Europeo Di Oncologia Milan,
Linear Clinical Research Nedlands, Western Australia
Lions Gate Hospital Chemotherapy Clinic North Vancouver, British Columbia
Mayo Clinic Rochester Rochester, Minnesota
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Memorial Sloan Kettering Cancer Center MSKCC New York, New York
Mission Cancer and Blood Waukee, Iowa
Monash Health Clayton, Victoria
Nhs Highland Inverness,
Northwestern Medicine Cancer Center Warrenville, Illinois
Ohio State University Comprehensive Cancer Center Columbus, Ohio
Plymouth Hospitals NHS Trust Plymouth,
Princess Alexandra Hospital Woolloongabba, Queensland
Princess Margaret Cancer Centre Toronto, Ontario
QEII Health Science Center Halifax, Nova Scotia
Royal Marsden Nhs Foundation Royal Marsden Hospital Sutton,
Royal Perth Hospital Perth, Western Australia
Shengjing Hospital of China Medical Universityshenbei Branch Shenyang, Liaoning
St Jamess University Hospital Leeds,
St Vincents Hospital Melbourne Fitzroy, Victoria
The Affiliated Hospital of Qingdao University Branch South Qingdao, Shandong
The Christie Nhs Foundation Trust Manchester Manchester,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Xiamen University Xiamen, Fujian
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang
The First Hospital of Jiaxing Jiaxing, Zhejiang
The Third Peoples Hospital of Datong Datong, Shanxi
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei
UT Southwestern Medical Center Dallas, Texas
University College Hospital London,
University Hospitals Dorset Bournemouth,
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore, Maryland
University of Miami Miami, Florida
University of Washington Seattle, Washington
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Yancheng First Peoples Hospital Yancheng, Jiangsu

Caring and Coping with Cancer (C3) (C3)

Winter, Marcia - mawinter@vcu.edu

Winter, Marcia
14620
HM20014307
Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
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Virginia Commonwealth University Richmond, Virginia Winter, Marcia - (mawinter@vcu.edu)

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com

NCT04094610
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Key
Inclusion Criteria:

• Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
• Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
• Prior cytotoxic chemotherapy is allowed.
• Prior immunotherapy is allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
• Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
• Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
• Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
• Adequate hematologic, renal and hepatic function. Phase 2
Inclusion Criteria:

• Cohort Specific
Inclusion Criteria:
* Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve; * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated; * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.
• Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2):
• Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
• Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
• Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
• Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
• Peripheral neuropathy of CTCAE ≥grade 2.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
• Any potential allergies to repotrectinib and/or its excipients.
DRUG: Oral repotrectinib (TPX-0005)
Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric
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Alder Hey Children's NHS Foundation Trust Liverpool, England
Asan Medical Center Seoul,
Baylor College of Medicine Houston, Texas
Centre Hospitalier Universitaire d'Angers Angers,
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux,
Children's Health Queensland Hospital and Health Service South Brisbane, Queensland
Children's Healthcare of Atlanta - Egleston Hospital Atlanta, Georgia
Children's Hospital Colorado - Anschutz Medical Campus Aurora, Colorado
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital of Philadelphia-Center for Childhood Cancer Research Philadelphia, Pennsylvania
Children's Hospital of Richmond at VCU Richmond, Virginia
Clinica Universidad de Navarra Madrid,
Clinica Universidad de Navarra Madrid,
Dana Farber Cancer Institute. Boston, Massachusetts
Fondazione IRCCS - Istituto Nazionale dei Tumori Milan,
Great Ormond Street Hospital for Children NHS Foundation Trust London,
HM Sanchinarro University Hospital Madrid,
Hospital Infantil Universitario Nino Jesus Madrid,
Hospital Sant Joan de Deu Esplugues de Llobregat, Barcelona
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario y Politécnico La Fe Valencia,
Hôpitaux Universitaires de Marseille Timone Marseille,
Institut Gustave-Roussy Villejuif,
Institut d Hematologie et d Oncologie Pediatriques Lyon,
KK Women's and Children's Hospital Singapore,
Levine Children's Hospital- Pediatric Neuro-Oncology Charlotte, North Carolina
Local Institution - 2104 Houston, Texas
Local Institution - 2105 Orlando, Florida
Local Institution - 2110 New Brunswick, New Jersey
Local Institution - 2112 Cleveland, Ohio
Local Institution - 2114 Hershey, Pennsylvania
Local Institution - 2120 Orlando, Florida
Local Institution - 4302 Rome,
Local Institution - 4403 Birmingham,
Local Institution - 6103 Westmead, New South Wales
Local Institution - 6104 Randwick, New South Wales
Local Institution - 6105 Barcelona,
Local Institution - 6106 Madrid,
Local Institution - 6107 Valencia,
Local Institution - 6108 Villejuif,
Local Institution - 6109 Paris,
Local Institution - 6110 Marseille,
Local Institution - 6111 Lyon, Rhone
Local Institution - 6112 Nantes,
Local Institution - 6113 Padua,
Local Institution - 6114 Torino,
Local Institution - 6303 Seoul, Seodaemun-gu
Local Institution - 6304 Seoul,
Maine Medical Center Scarborough, Maine
Memorial Sloan-Kettering Cancer Center. New York, New York
National Taiwan University Hospital Taipei,
National University Hospital Kent Ridge,
Perth Childrens Hospital Nedlands, Western Australia
Rigshospitalet - Glostrup Copenhagen,
Royal Hosp. for Children Glasgow,
Seoul National University Hospital Seoul,
St Justine Hospital Montreal, Quebec
St. Jude Children's Research Hospital Memphis, Tennessee
Stollery Children's Hospital Edmonton, Alberta
Taipei Medical University Hospital Taipei,
The Royal Marsden NHS Foundation Trust London,
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center Dallas, Texas
University Hospital of Wales Cardiff,
University of Calgary Calgary, Alberta
University of California at Los Angeles Los Angeles, California
Washington University School of Medicine in St. Louis St Louis, Missouri

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics (COSMIC)

Karen Craver - NCORP@wfusm.edu

NCT06418204
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Inclusion Criteria:
* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified). * Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment. * Participants must be able to comprehend English or Spanish (for survey completion). * Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location. * Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment. * Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey * In the treating provider's opinion, the participant should have a life expectancy of \>=6 months. Participants in hospice are not eligible. Optional Sub-study (available at select sites only): * Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU). * Must be receiving treatment at the WF CCC and VCU. * Must be diagnosed with non-small cell lung cancer. * Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
Exclusion Criteria:
* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. * Participants with known pregnancy. * Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy. * Participants enrolled in hospice. Optional Substudy (available at select sites only): * Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed. * Participants with a history of HIV, hepatitis B or hepatitis C.
OTHER: Non-interventional Study
Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma, Melanoma, Non-Hodgkin Lymphoma
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AMG Crystal Lake - Oncology Crystal Lake, Illinois - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate High Tech Medical Park Palos Heights, Illinois - (ncorp@aah.org)
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois - (ncorp@aah.org)
Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois - (ncorp@aah.org)
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
AnMed Health Cancer Center Anderson, South Carolina - (rhonda.ballew@anmedhealth.org)
Armes Family Cancer Center Findlay, Ohio - (clinical.trials@daytonncorp.org)
Ascension All Saints Hospital Racine, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital Chilton, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin - (AWRI.Inquiry@Ascension.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Langlade Hospital Antigo, Wisconsin - (Juli.Alford@aspirus.org)
Aspirus Medford Hospital Medford, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina
Atrium Health Navicent Macon, Georgia - (andrew.weatherall@atriumhealth.org)
Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina
Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina
Atrium Health Union/LCI-Union Monroe, North Carolina
Atrium Health University City/LCI-University Charlotte, North Carolina
Augusta Health Center for Cancer and Blood Disorders Fishersville, Virginia
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin - (ncorp@aurora.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital for Women Memphis, Tennessee - (BCCclintrials@bmhcc.org)
Beaufort Memorial Hospital Beaufort, South Carolina - (kwade@bmhsc.org)
Beebe Health Campus Rehoboth Beach, Delaware - (research@beebehealthcare.org)
Beebe South Coastal Health Campus Millville, Delaware - (research@beebehealthcare.org)
Benefis Sletten Cancer Institute Great Falls, Montana - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana - (research@billingsclinic.org)
Blanchard Valley Hospital Findlay, Ohio - (clinical.trials@daytonncorp.org)
Bozeman Health Deaconess Hospital Bozeman, Montana - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan - (crcwm-regulatory@crcwm.org)
CHI Health Good Samaritan Kearney, Nebraska - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Hematology Centers - Flint Flint, Michigan - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois - (Research@carle.com)
Carle at The Riverfront Danville, Illinois - (Research@Carle.com)
CaroMont Health - Lincoln Cancer Center Lincolnton, North Carolina
CaroMont Regional Medical Center Gastonia, North Carolina - (tammy.cozad@caromonthealth.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia - (Kevin.Patel@centrahealth.com)
CentraState Medical Center Freehold, New Jersey
Centralia Oncology Clinic Centralia, Illinois - (morganthaler.jodi@mhsil.com)
Chilton Medical Center Pompton, New Jersey
Christiana Care - Union Hospital Elkton, Maryland - (frank.crum@christianacare.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota - (coborncancercenter@centracare.com)
Colorado Blood Cancer Institute Denver, Colorado - (info@westernstatesncorp.org)
Community Hospital of Anaconda Anaconda, Montana - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana - (HemonCCTrials@geisinger.edu)
Condell Memorial Hospital Libertyville, Illinois - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Contra Costa Regional Medical Center Martinez, California
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan - (crcwm-regulatory@crcwm.org)
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Cox Health South Hospital Springfield, Missouri
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC - Englewood Dayton, Ohio - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois - (morganthaler.jodi@mhsil.com)
Duluth Clinic Ashland Ashland, Wisconsin - (CancerTrials@EssentiaHealth.org)
Edwards Comprehensive Cancer Center Huntington, West Virginia - (Christina.Cole@chhi.org)
Englewood Hospital and Medical Center Englewood, New Jersey
Ephrata Cancer Center Ephrata, Pennsylvania
Essentia Health - Deer River Clinic Deer River, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health - Fosston Fosston, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health - Park Rapids Park Rapids, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota - (CancerTrials@EssentiaHealth.org)
Fairbanks Memorial Hospital Fairbanks, Alaska - (Veronica.Stevenson@foundationhealth.org)
Fairview Northland Medical Center Princeton, Minnesota - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky - (ResearchInstituteInquiries@CommonSpirit.org)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania - (hemoncctrials@geisinger.edu)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan - (wstrong@ghci.org)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina - (kmertz-rivera@gibbscc.org)
Glens Falls Hospital Glens Falls, New York Misty J DeCaro - (lacrosmj@glensfallshosp.org)
Greater Dayton Cancer Center Kettering, Ohio - (clinical.trials@daytonncorp.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois - (morganthaler.jodi@mhsil.com)
Hackettstown Medical Center Hackettstown, New Jersey
Harold Alfond Center for Cancer Care Augusta, Maine
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii - (i.webster@hawaiicancercare.com)
HaysMed Hays, Kansas
Hayworth Cancer Center High Point, North Carolina
Heartland Regional Medical Center Saint Joseph, Missouri - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware - (lbarone@christianacare.org)
Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia - (cvaughn@hoafredericksburg.com)
Hennepin County Medical Center Minneapolis, Minnesota - (mmcorc@healthpartners.com)
Hi-Line Sletten Cancer Center Havre, Montana - (mccinfo@mtcancer.org)
Holy Name Hospital Teaneck, New Jersey
Illinois CancerCare - Washington Washington, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois - (andersonj@illinoiscancercare.com)
Indu and Raj Soin Medical Center Beavercreek, Ohio - (clinical.trials@daytonncorp.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Healthcare Port Townsend, Washington
Kadlec Clinic Hematology and Oncology Kennewick, Washington - (research@kadlecmed.org)
Kaiser Permanente Bellevue Medical Center Bellevue, Washington - (KPWAoncologytrials@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, California
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California - (Kpoct@kp.org)
Kaiser Permanente Medical Center-Vacaville Vacaville, California - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii - (shelley.a.clark@kp.org)
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Regional Cancer Care - Jesup Jesup, Georgia - (Oncologyresearch@sjchs.org)
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Rush-Copley Healthcare Center Yorkville, Illinois - (Cancer.Research@rushcopley.com)
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SMC Center for Hematology Oncology Union Union, South Carolina - (kmertz-rivera@gibbscc.org)
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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Toll Free Number - Trialsites@msd.com

NCT06074588
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations. * Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1. * Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI. * Measurable disease per RECIST 1.1 as assessed by the local site investigator. * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Exclusion Criteria:
* Has predominantly squamous cell histology NSCLC. * Has mixed tumor(s) with small cell elements. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib). * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. * Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention. * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC). * Received prior treatment with a topoisomerase I-containing ADC. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Active infection requiring systemic therapy. * History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD. * Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Docetaxel, DRUG: Pemetrexed
Non-small Cell Lung Cancer (NSCLC)
Anaplastic lymphoma kinase (ALK), Antibody-drug conjugate (ADC), Epidermal growth factor receptor (EGFR), Trophoblast cell-surface antigen 2 (TROP2)
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Study Locations

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Location Contacts
"Theagenio" Cancer Hospital of Thessaloniki ( Site 2703) Thessaloniki, Central Macedonia
A. C. Camargo Cancer Center-CAPEC ( Site 0442) São Paulo,
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704) Chaidari, Athens, Attica
Adana Medical Park Seyhan Hastanesi ( Site 2506) Adana,
Aichi Cancer Center ( Site 3400) Nagoya, Aichi-ken
Anhui Provincial Cancer Hospital ( Site 2830) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501) Ankara,
Aretaieio Hospital ( Site 2702) Athens, Attica
Asan Medical Center ( Site 3801) Seoul,
Asian Hospital and Medical Center ( Site 3605) Muntinlupa, National Capital Region
Asklepios Klinik Harburg ( Site 1403) Hamburg,
Atlantic Health System Morristown Medical Center ( Site 0031) Morristown, New Jersey
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810) Beijing, Beijing Municipality
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815) Beijing, Beijing Municipality
Bradfordhill-Clinical Area ( Site 0507) Santiago, Region M. de Santiago
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602) San Juan City, Metro Manila, National Capital Region
CENTRE LEON BERARD ( Site 1305) Lyon Cedex08, Auvergne-Rhône-Alpes
CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300) Rouen, Haute-Normandie
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706) Guadalajara, Jalisco
Cancer Institute Hospital of JFCR ( Site 3402) Koto, Tokyo
Capital Health Medical Center - Hopewell ( Site 0006) Pennington, New Jersey
Centro Investigacion Cancer James Lind ( Site 0513) Temuco, Región de la Araucanía
Centro de Estudios Clínicos SAGA ( Site 0517) Santiago, Region M. de Santiago
Centro de Investigacion Clinica de Oaxaca ( Site 0701) Oaxaca City, Oaxaca
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003) Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906) Kaohsiung City,
Changhua Christian Hospital ( Site 3908) Changhua,
Chi Mei Medical Center ( Site 3910) Tainan City, Tainan
Chiba University Hospital ( Site 3411) Chiba,
Chongqing University Cancer Hospital-Medical Oncology ( Site 2814) Chongqing, Chongqing Municipality
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807) Hwasun, Jeonranamdo
Chungbuk National University Hospital-Internal medicine ( Site 3809) Cheongju-si, North Chungcheong
Chungnam national university hospital ( Site 3808) Junggu, Taejon-Kwangyokshi
Clinica Integral Internacional de Oncología ( Site 0705) Puebla City,
Clinica Universidad Catolica del Maule-Oncology ( Site 0501) Talca, Maule Region
Clinica Universidad de Navarra-Medical Oncology ( Site 2306) Madrid,
Clínica RedSalud Vitacura ( Site 0511) Santiago, Region M. de Santiago
E-Da hospital ( Site 3911) Kaohsiung City,
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504) Bornova, İzmir
Englewood Hospital and Medical Center ( Site 0033) Englewood, New Jersey
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705) Athens, Attica
FALP-UIDO ( Site 0509) Santiago, Region M. de Santiago
Faculty of Medicine - Khon Kaen University ( Site 4004) Khon Kaen,
Faculty of Medicine Siriraj Hospital ( Site 4000) Bangkok, Bangkok
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102) Olomouc,
Fakultni nemocnice Plzen ( Site 1104) Pilsen, Plzeň Region
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800) Milan, Lombardy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802) Rome, Lazio
Fudan University Shanghai Cancer Center-Oncology ( Site 2811) Shanghai, Shanghai Municipality
Fujian Cancer Hospital ( Site 2819) Fuzhou, Fujian
Fujita Health University Hospital ( Site 3419) Toyoake, Aichi-ken
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444) Barretos, São Paulo
Groupe hospitalier Paris saint Joseph. ( Site 1307) Paris,
Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816) Nanning, Guangxi
Gunma Prefectural Cancer Center ( Site 3418) Otashi, Gunma
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603) London, London, City of
H.R.U Málaga - Hospital General-Oncology ( Site 2302) Málaga, Malaga
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304) Barcelona, Catalonia
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303) Madrid, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301) Pozuelo de Alarcón, Madrid
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500) Ankara,
Hanoi Oncology Hospital ( Site 4102) Hanoi, Hanoi
Harbin Medical University Cancer Hospital-oncology of department ( Site 2807) Harbin, Heilongjiang
Hattiesburg Clinic Hematology/Oncology ( Site 0010) Hattiesburg, Mississippi
Henan Cancer Hospital-henan cancer hospital ( Site 2813) Zhengzhou, Henan
Hong Kong Integrated Oncology Centre ( Site 3200) Central,
Hospital Insular de Gran Canaria-Oncology ( Site 2305) Las Palmas de Gran Canaria, Las Palmas
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440) Porto Alegre, Rio Grande do Sul
Hospital Paulistano-Americas Oncologia ( Site 0441) São Paulo,
Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502) Kota Bharu, Kelantan
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300) Barcelona,
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704) Monterrey, Nuevo León
Hubei Cancer Hospital ( Site 2809) Wuhan, Hubei
Hunan Cancer Hospital-thoracic oncology II ( Site 2808) Changsha, Hunan
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806) Meldola, Emilia-Romagna
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303) Bordeaux, Aquitaine
Institut Curie-Thorax Institute ( Site 1304) Paris,
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011) Warsaw, Masovian Voivodeship
Istituto Clinico Humanitas ( Site 1803) Rozzano, Lombardy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805) Rome, Roma
Jilin Province Tumor Hospital-clinical research ( Site 2803) Changchun, Jilin
Jinan Central Hospital-oncology department ( Site 2802) Jinan, Shandong
K Hospital - National Cancer Hospital ( Site 4105) Hanoi, Hanoi
K2 Oncology ( Site 0514) Santiago, Region M. de Santiago
Kanagawa Cancer Center ( Site 3404) Yokohama, Kanagawa
Kanazawa University Hospital ( Site 3414) Kanazawa, Ishikawa-ken
Kangbuk Samsung Hospital ( Site 3813) Seoul,
Kansai Medical University Hospital ( Site 3410) Hirakata, Osaka
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912) Kaohsiung City,
Karmanos Cancer Institute ( Site 0018) Detroit, Michigan
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400) Essen, North Rhine-Westphalia
Klinikum Chemnitz - Flemmingstraße ( Site 1401) Chemnitz, Saxony
Konkuk University Medical Center ( Site 3812) Seoul,
Korea University Guro Hospital-Internal Medicine ( Site 3800) Seoul,
Kyushu University Hospital ( Site 3407) Fukuoka,
Lampang Cancer Hospital ( Site 4005) Muang, Changwat Lampang
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447) Natal, Rio Grande do Norte
LinYi Cancer Hospital ( Site 2804) Linyi, Shandong
Mackay Memorial Hospital-Chest Medicine ( Site 3902) Taipei,
Maharaj Nakorn Chiang Mai Hospital ( Site 4003) Muang, Chiang Mai
Manila Doctors Hospital-Clinical Trial Office ( Site 3604) Manila, National Capital Region
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100) Brno, Brno-mesto
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) Jacksonville, Florida
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) Rochester, Minnesota
Medipol Mega Universite Hastanesi-oncology ( Site 2505) Stanbul, Istanbul
Mid Florida Hematology and Oncology Center ( Site 0005) Orange City, Florida
Miyagi Cancer Center ( Site 3416) Natori-shi, Miyagi
Monash Health-Oncology Research ( Site 3001) Clayton, Victoria
Nanjing Drum Tower Hospital ( Site 2812) Nangjing, Jiangsu
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000) Warsaw, Masovian Voivodeship
National Cancer Center Hospital East ( Site 3406) Kashiwa, Chiba
National Cancer Center-Lung Cancer Center ( Site 3810) Goyang-si, Kyonggi-do
National Cancer Institute-Radiotherapy and Oncology ( Site 3504) Putrajaya, Kuala Lumpur
National Cheng Kung University Hospital ( Site 3909) Tainan City,
National Hospital Organization Kyushu Medical Center ( Site 3412) Fukuoka,
National Hospital Organization Shikoku Cancer Center ( Site 3415) Matsuyama, Ehime
National Lung Hospital-Oncology Department ( Site 4104) Hanoi, Hanoi
National Taiwan University Cancer Center (NTUCC) ( Site 3903) Taipei City, Taipei
National Taiwan University Hospital - Hsinchu branch ( Site 3907) Hsinchu,
National Taiwan University Hospital-Oncology ( Site 3904) Taipei,
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103) Ostrava, Ostrava Mesto
Niigata Cancer Center Hospital ( Site 3405) Niigata, Niigata
Nippon Medical School Hospital ( Site 3408) Tokyo,
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) Marietta, Georgia
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446) São Paulo,
ONCOCENTRO APYS-ACEREY ( Site 0500) Viña del Mar, Región de Valparaíso
Okayama University Hospital ( Site 3417) Okayama,
Orlandi Oncologia-Oncology ( Site 0504) Santiago, Region M. de Santiago
Osaka International Cancer Institute ( Site 3413) Osaka,
Papageorgiou General Hospital of Thessaloniki ( Site 2701) Thessaloniki,
Pontificia Universidad Catolica de Chile ( Site 0502) Santiago, Region M. de Santiago
Princess Margaret Cancer Centre ( Site 0204) Toronto, Ontario
Princess Margaret Hospital-Department of Oncology ( Site 3201) Lai Chi Kok,
Pusan National University Hospital ( Site 3805) Busan, Pusan-Kwangyokshi
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811) Yangsan, Kyongsangnam-do
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204) Kowloon,
Queen Mary Hospital ( Site 3203) Hksar,
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606) London, Kensington and Chelsea
Rabin Medical Center ( Site 1703) Petah Tikva,
Rambam Health Care Campus-Oncology Division ( Site 1702) Haifa,
Royal Marsden Hospital (Sutton) ( Site 2605) Sutton, Surrey
ST. LUKE'S MEDICAL CENTER ( Site 3601) Quezon City, National Capital Region
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802) Seoul,
Sarawak General Hospital-Radiotherapy Unit ( Site 3500) Kuching, Sarawak
Sendai Kousei Hospital ( Site 3401) Sendai, Miyagi
Seoul National University Bundang Hospital ( Site 3806) Seongnam, Kyonggi-do
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804) Seoul,
Shaare Zedek Medical Center ( Site 1700) Jerusalem,
Shanghai Chest Hospital-Oncology department ( Site 2800) Shanghai, Shanghai Municipality
Shizuoka Cancer Center ( Site 3403) Nagaizumi-cho,Sunto-gun, Shizuoka
Sichuan Cancer hospital. ( Site 2822) Chengdu, Sichuan
Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828) Hangzhou, Zhejiang
Songklanagarind hospital ( Site 4001) Hat Yai, Changwat Songkhla
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818) Guangzhou, Guangdong
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600) London, London, City of
St. George Private Hospital ( Site 3004) Kogarah, New South Wales
Sunpasitthiprasong Hospital-Oncology ( Site 4002) Ubon Ratchathani,
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005) Kielce, Świętokrzyskie Voivodeship
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) Istanbul,
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600) Iloilo City, Iloilo
THE MEDICAL CITY-Cancer Research Center ( Site 3603) Pasig, National Capital Region
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700) Athens, Attica
Taipei Medical University Hospital ( Site 3900) Taipei,
Takarazuka City Hospital ( Site 3409) Takarazuka, Hyōgo
Tennessee Oncology (0036) Nashville, Tennessee Tamjeed Ahmed - (tahmed@tnonc.com)
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803) Suwon, Kyonggi-do
The Christie NHS Foundation Trust ( Site 2604) Manchester,
The Clatterbridge Cancer Centre ( Site 2602) Metropolitan Borough of Wirral,
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817) Xi'an, Shaanxi
The First Affiliated hospital of Xiamen University ( Site 2820) Xiamen, Fujian
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821) Nanchang, Jiangxi
The Second Xiangya Hospital of Central South University ( Site 2827) Changsha, Hunan
Tongji Hospital Tongji Medical,Science & Technology ( Site 2805) Wuhan, Hubei
UCLA Hematology/Oncology - Santa Monica ( Site 0023) Los Angeles, California
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402) Dresden, Saxony
Universitaetsklinikum Freiburg ( Site 1405) Freiburg, Brandenburg
University Of Nebraska Medical Center ( Site 0011) Omaha, Nebraska
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015) Cincinnati, Ohio
University of Texas MD Anderson (0037) Houston, Texas Yasir Elamin - (yyelamin@mdanderson.org)
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407) Göttingen, Lower Saxony
VCU Health Adult Outpatient Pavillion ( Site 0026) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105) Prague,
West China Hospital, Sichuan University-Lung cancer center ( Site 2826) Chengdu, Sichuan
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) Melbourne, Victoria
Westmead Hospital ( Site 3000) Westmead, New South Wales
William Osler Health System ( Site 0205) Brampton, Ontario
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009) Torun, Kuyavian-Pomeranian Voivodeship
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001) Przemyśl, Podkarpackie Voivodeship
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806) Wuhan, Hubei
Yunnan Province Cancer Hospital ( Site 2824) Kunming, Yunnan
Zhejiang Cancer Hospital ( Site 2829) Hangzhou, Zhejiang

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Griffin, Jordyn
NCT03959085
HM20018568
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Inclusion Criteria:
* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol. * APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732. * Patients must be \> 365 days and \< 25 years of age * White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-9.99 years: WBC \>= 50,000/uL * Age 10-24.99 years: Any WBC * Age 1-9.99 years: WBC \< 50,000/uL with: * Testicular leukemia * CNS leukemia (CNS3) * Steroid pretreatment. * White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction. * Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% blasts on a bone marrow (BM) aspirate; * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy; * OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed. * Patient has newly diagnosed B-LLy Murphy stages III or IV. * Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment. * Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted. * Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
* Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group). * With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732. * Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy. * Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells. * Patients with acute undifferentiated leukemia (AUL) are not eligible. * For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply: * T-lymphoblastic lymphoma. * Morphologically unclassifiable lymphoma. * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma. * Patients with known Charcot-Marie-Tooth disease. * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype. * Patients requiring radiation at diagnosis. * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Atrium Health Navicent Macon, Georgia Site Public Contact - (andrew.weatherall@atriumhealth.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars Sinai Medical Center Los Angeles, California
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
Edwards Comprehensive Cancer Center Huntington, West Virginia
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health Saint John Hospital Detroit, Michigan
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Janeway Child Health Centre St. John's, Newfoundland and Labrador Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
Jersey Shore Medical Center Neptune City, New Jersey
Jim Pattison Children's Hospital Saskatoon, Saskatchewan Site Public Contact - (Jessica.Marien@saskhealthauthority.ca)
John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mattel Children's Hospital UCLA Los Angeles, California
Mayo Clinic in Rochester Rochester, Minnesota
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Miami Cancer Institute Miami, Florida
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Monash Medical Center-Clayton Campus Clayton, Victoria
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Naval Medical Center -San Diego San Diego, California
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Palms West Radiation Therapy Loxahatchee Groves, Florida
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Santa Barbara Cottage Hospital Santa Barbara, California
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Scott and White Memorial Hospital Temple, Texas
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada
Sutter Medical Center Sacramento Sacramento, California
T C Thompson Children's Hospital Chattanooga, Tennessee
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Tufts Children's Hospital Boston, Massachusetts
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UMC Cancer Center / UMC Health System Lubbock, Texas
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vannie Cook Children's Clinic McAllen, Texas
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wesley Medical Center Wichita, Kansas Site Public Contact - (WesleyResearch@wesleymc.com)
West Virginia University Charleston Division Charleston, West Virginia
West Virginia University Healthcare Morgantown, West Virginia
Women's and Children's Hospital-Adelaide North Adelaide, South Australia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

ctrrecruit@vcu.edu

NCT04726241
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Inclusion Criteria:
* Patients must be less than 22 years of age at the time of study enrollment * Patient must have one of the following at the time of study enrollment: * Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol * This includes isolated myeloid sarcoma * Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS) * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria: * Second or greater B-ALL medullary relapse, excluding KMT2Ar * Any first or greater B-ALL medullary relapse involving KMT2Ar * Any first or greater T-ALL medullary relapse with or without KMT2Ar * Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
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Show 181 locations

Study Locations

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Location Contacts
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Cleveland Clinic Foundation Cleveland, Ohio
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Nicklaus Children's Hospital Miami, Florida
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UMC Cancer Center / UMC Health System Lubbock, Texas
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Kenneth B. De Santes - (kbdesantes@pediatrics.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Virginia University Healthcare Morgantown, West Virginia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Lisa Erickson, MPH - 10-CBA@ndmp.org

McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs * Cord blood transplant recipients at international transplant centers * Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) * Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Rushang Patel, MD - (rushang.patel.md@adventhealth.com)
Advocate Lutheran General Hospital Park Ridge, Illinois
All Children's Hospital St. Petersburg, Florida Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu)
Amarillo Blood and Marrow Transplant Program Amarillo, Texas
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Sonali Chaudhury, MD - (schaudhury@luriechildrens.org)
Arkansas Children's Hospital Little Rock, Arkansas Jason Farrar, MD - (JEFarrar@uams.edu)
Avera Transplant Institute Sioux Falls, South Dakota Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org)
Banner MD Anderson Cancer Center Gilbert, Arizona September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com)
Beth Israel Deaconess Boston, Connecticut
Cardinal Glennon Children's Medical Center St Louis, Missouri Deepika Bhatla, MD - (dbhatla@slu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Ann Haight, MD - (Ann.haight@choa.org)
Children's Hospital Colorado Aurora, Colorado Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU)
Children's Hospital and Research Center of Oakland Oakland, California Mark Walters, MD - (mwalters@mail.cho.org)
Children's Hospital at Montefiore The Bronx, New York Mahvish Rahim, MD - (mrahim@montefiore.org)
Children's Hospital of Los Angeles Los Angeles, California Neena Kapoor, MD - (nkapoor@chla.usc.edu)
Children's Hospital of Michigan Detroit, Michigan Sureyya Savasan, MD - (ssavasan@med.wayne.edu)
Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana Lolie Yu, MD - (lyu@lsuhsc.edu)
Children's Hospital of Orange County (CHOC) Orange, California Rishikesh Chavan, MD - (rishikesh.chavan@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Nancy Bunin, MD - (buninn@email.chop.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Paul Szabolcs, MD - (Paul.szabolcs@chp.edu)
Children's Hospital of Wisconsin Milwaukee, Wisconsin David Margolis, MD - (dmargoli@mcw.edu)
Children's Medical Center Dallas Dallas, Texas Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu)
Children's Mercy Hospital and Clinics Kansas City, Missouri
Children's National Medical Center Washington D.C., District of Columbia David Jacobsohn, MD - (dajacobs@childrensnational.org)
Childrens Hospital Medical Center of Akron Akron, Ohio Megan Sampson, MD - (msampson@akronchildrens.org)
Cincinnati Children's Hospital Cincinnati, Ohio Stella Davies, MD - (stella.davies@cchmc.org)
City of Hope Duarte, California Monzr Al Malki, MD - (malmalki@coh.org)
Cleveland Clinic Cleveland, Ohio Craig Sauter, MD - (sauterc@ccf.org)
Cohen Children's Medical Center of New York New Hyde Park, New York Jonathan Fish, MD - (jfish1@nshs.edu)
Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York Monica Bhatia, MD - (mb2476@columbia.edu)
Cook Children's Hospital Fort Worth, Texas Gretchen Eames, MD - (gretchen.eames@cookchildrens.org)
Dana Farber Cancer Institute Boston, Massachusetts Corey Cutler, MD - (cscutler@partners.org)
Duke University Medical Center Durham, North Carolina Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu)
Emory University Hospital Atlanta, Georgia
Florida Center for Pediatric Cellular Therapy Orlando, Florida Susan Kelly, MD - (susan.kelly.md@flhosp.org)
Fred Hutchinson Cancer Research Center Seattle, Washington Ann Dahlberg, MD - (adahlber@fredhutch.org)
Greenebaum Cancer Center - University of Maryland Baltimore, Maryland
H Lee Moffitt Cancer Center Tampa, Florida
Hackensack University Medical Center Hackensack, New Jersey Alfred Gillio, MD - (agillio@humed.com)
Helen DeVos Children's Hospital Grand Rapids, Michigan Troy Quigg, MD - (troy.quigg@spectrumhealth.org)
Henry Ford Health System Jackson, Michigan Nalini Janakiraman, MD - (njanaki1@hfhs.org)
Indiana Blood & Marrow Transplantation Beech Grove, Indiana Luke Akard, MD - (lakard@ibmtindy.com)
Indiana University/Riley Hospital for Children Indianapolis, Indiana Jodi Skiles, MD - (jskiles@iu.edu)
Johns Hopkins Baltimore, Maryland Allen Chen, MD, PhD - (allenchen@jhmi.edu)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii Randal Wada, MD - (randalw@hawaii.edu)
Karmanos Cancer Institute Detroit, Michigan
Levine Children's Hospital Charlotte, North Carolina Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org)
Loma Linda University Cancer Center Loma Linda, California Hisham Abdel-Azim, MD - (habdelazim@llu.edu)
Loyola University Medical Center Maywood, Illinois Patrick Stiff, MD - (pstiff@lumc.edu)
M.D. Anderson Cancer Center Houston, Texas Elizabeth Shpall, MD - (eshpall@mdanderson.org)
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida Vivek Roy, MD - (roy.vivek@mayo.edu)
Mayo Clinic Arizona (adults) Phoenix, Arizona James Slack, MD - (slack.james@mayo.edu)
Mayo Clinic Rochester Rochester, Minnesota
Medical City Dallas Dallas, Texas Vikas Bhushan, MD - (vikas.bhushan@usoncology.com)
Medical College of Georgia Augusta, Georgia Claude Sportes, MD - (csportes@gru.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Hamadani Mehdi, MD - (mhamadani@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Michelle Hudspeth, MD - (hudspeth@musc.edu)
Memorial Sloan-Kettering Cancer Center New York, New York Ioannis Politikos, MBBS - (politiki@mskcc.org)
Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com)
Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com)
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Medical Center Miami Beach, Florida Alla Keyzner, MD - (alla.keyzner@mssm.edu)
NIH/NCI Bethesda, Maryland
Nationwide Children's Hospital Columbus, Ohio Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org)
Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware Emi Caywood, MD - (ecaywood@nemours.org)
Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida Michael Joyce, MD - (mjoyce@nemours.org)
New York Presbyterian Hospital at Cornell New York, New York Tsiporah Shore, MD - (tbs2001@med.cornell.edu)
New York University Langone Medical Center New York, New York A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.org)
Nih/Nhlbi Bethesda, Maryland Richard Childs, MD - (childsr@nih.gov)
Nih/Niaid Bethesda, Maryland Elizabeth Kang, MD - (ekang@niaid.nih.gov)
Niklaus Children's Hospital Miami, Florida Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org)
North Shore University Hospital Manhasset, New York Ruthee L Bayer, MD - (rbayer@nshs.edu)
Northside Hospital Atlanta, Georgia Scott Solomon, MD - (ssolomon@bmtga.com)
Northwestern Memorial Hospital Chicago, Illinois Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu)
Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon Eneida Nemecek, MD - (nemeceke@ohsu.edu)
Orlando Health Bone Marrow Transplant and Cellular Therapy Orlando, Florida Yasser Khaled, MD - (yasser.khaled@orlandohealth.com)
Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu)
Phoenix Children's Hospital Phoenix, Arizona
Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com)
Rady Children's Hospital San Diego San Diego, California Eric Anderson, MD - (eanderson@rchsd.org)
Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu)
Roger Williams Medical Center Providence, Rhode Island Todd Roberts, MD - (todd.roberts@chartercare.org)
Roswell Park Cancer Institute Buffalo, New York Philip McCarthy, MD - (philip.mccarthy@roswellpark.org)
Rush University Medical Center Chicago, Illinois
Sarah Cannon BMT Program Nashville, Tennessee
Scripps Green Hospital La Jolla, California Jeffrey W Andrey, MD - (andrey.jeffrey@scrippshealth.org)
Southwest Cancer Treatment & Research Center Lubbock, Texas
Spectrum Health Grand Rapids, Michigan Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org)
St. Jude Childrens Research Hospital Memphis, Tennessee Renee Madden, MD - (renee.madden@stjude.org)
St. Louis University Medical Center St. Louis, Missouri Sagun Goyal, MD - (sgoyal3@slu.edu)
Stanford University Medical Center Palo Alto, California Andrew Rezvani, MD - (arezvani@stanford.edu)
Stony Brook University Hospital Stony Brook, New York Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu)
Strong Memorial Hospital/University of Rochester Rochester, New York Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu)
Sutter Medical Center Sacramento, California Michael Carroll, MD - (carrolmp@sutterhealth.org)
Texas Children's Hospital - Baylor Medical Center Houston, Texas Robert Krance, MD - (rakrance@txch.org)
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio Sumithira Vasu, MD - (sumithira.vasu@osumc.edu)
The Children's Hospital of San Antonio San Antonio, Texas Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org)
The Jewish Hospital Cincinnati, Ohio
Tufts Medical Center Boston, Massachusetts Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org)
Tulane Medical Center New Orleans, Louisiana Hana Safa, MD - (hsafah@tulane.edu)
UCLA Santa Monica, California Gary Schiller, MD - (gschiller@mednet.ucla.edu)
UCSF (adults) San Francisco, California
UCSF (peds) San Francisco, California
Univeristy of Mississippi Medical Center Jackson, Mississippi Carolyn Bigelow, MD - (cbigelow@umc.edu)
University Hospitals Case Medical Center Cleveland, Ohio Hillard Lazarus, MD - (hillard.lazarus@case.edu)
University of Alabama at Birmingham Birmingham, Alabama Joseph Chewning, MD - (jchewning@peds.uab.edu)
University of Arizona Medical Center - Tucson Tucson, Arizona Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu)
University of California San Diego San Diego, California Edward Ball, MD - (tball@ucsd.edu)
University of Chicago Chicago, Illinois James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu)
University of Colorado Hospital Aurora, Colorado Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu)
University of Florida Shands Medical Center Gainesville, Florida Jordan Milner, MD - (jordan.milner@ufl.edu)
University of Illinois at Chicago Chicago, Illinois Damiano Rondelli, MD - (drond@uic.edu)
University of Iowa Iowa City, Iowa Margarida Silverman, MD - (margarida-silverman@uiowa.edu)
University of Kansas Westwood, Kansas Joseph McGuirk, DO - (jmcguirk@kumc.edu)
University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky William Tse, MD - (w0tse002@louisville.edu)
University of Massachusetts Worcester, Massachusetts Jan Cerny, MD - (Jan.Cerny@umassmemorial.org)
University of Miami (adult) Miami, Florida
University of Miami (peds) Miami, Florida
University of Michigan Ann Arbor, Michigan Jessica Yu - (jjxyu@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Phyllis Warkenton, MD - (pwarkent@unmc.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Oklahoma Health Science Center Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
University of Pennsylvania/Thomas Jefferson Pittsburg, Pennsylvania Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Alison Sehgal, MD - (sehgalar@upmc.edu)
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Salt Lake City, Utah Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu)
University of Virginia Charlottesville, Virginia Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu)
University of Wisconsin - Madison Madison, Wisconsin Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu)
VA Puget Sound HCS Seattle, Washington
VA Tennessee Valley Healthcare System Nashville, Tennessee
Vanderbilt University Nashville, Tennessee Michael Byrne, MD - (michael.byrne@vumc.org)
Virginia Commonwealth University Richmond, Virginia John McCarty, MD - (jmccarty@vcu.edu)
Wake Forest University Winston-Salem, North Carolina
Washington University St. Louis St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
Washington University/St. Louis Children's Hospital St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
West Virginia University Morgantown, West Virginia Lauren Veltri, MD - (lveltri@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Mitchell Cairo, MD - (mitchell_cairo@nymc.edu)
Western Penn Hospital Pittsburg, Pennsylvania John Lister, MD - (Jlister@wpahs.org)
Yale New Haven Hospital New Haven, Connecticut Aaron Flagg, MD - (aron.flagg@yale.edu)
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil)

Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation

Jewell, Andrea - Andrea.Jewell@vcuhealth.org

Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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Virginia Commonwealth University Richmond, Virginia Jewell, Andrea - (Andrea.Jewell@vcuhealth.org)

Longitudinal Cohort Registry of Cancer Survivors

Hong, Susan - susan.hong@vcuhealth.org

Hong, Susan
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
I'm interested
Share via email
Show 1 location

Study Locations

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Location Contacts
Virginia Commonwealth University Richmond, Virginia Hong, Susan - (susan.hong@vcuhealth.org)