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In-Home Adjustment of New Spinal Cord Injury Caregivers
Perrin, Paul, B - pperrin@vcu.edu
Perrin, Paul, B
NCT03244098
HM20009566
Inclusion Criteria:
SCI Patient Inclusion Criteria:
• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• demonstrate a clinician-rated loss in motor/sensory function on the ASIA scale (i.e., have a spinal cord injury) Caregiver
Inclusion Criteria:
• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• are a primary caregiver of the individual with SCI
• Caregivers with scores below 10 on the literacy screen will identify a family member or friend to review the guidebook with the caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver and function in that additional capacity
Exclusion Criteria:
• individual with SCI receives his/her primary care from a professional caregiver or other individual outside of the household besides the primary caregiver
• individuals with SCI or caregivers with known current uncontrolled substance dependence, aphasia, anosognosia (deficit in self-awareness), or treatment due to known self-inflicted injury
• individuals living alone
• prisoners
• SCI patient without decision making capacity to consent
Behavioral: Transition Assistance Program
Spinal Cord Injuries, External Causes of Injury and Poisoning (800-999)
Genome Transplant Dynamics (GTD NIH)
Sean T Agbor-Enoh, M.D. - agborenohst@mail.nih.gov
Shah, Keyur, B
NCT02423070
HM20004684
* INCLUSION CRITERIA:
* Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.
* Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
* 14 years and older
* Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
* Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.
EXCLUSION CRITERIA:
-Pregnancy
Thoracic Organ Transplantation
Cell-free DNA, Acute Rejection, Thoracic Organ Transplantation, Non-Invasive Testing, Chronic Rejection, Natural History
Myocardial Ischemia and Transfusion (MINT)
Jeffrey L Carson, MD - Jeffrey.Carson@Rutgers.edu
Kontos, Michael, C
NCT02981407
HM20010218
Inclusion Criteria:
• 18 years of age or older
• Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
• Hemoglobin concentration less than 10 g/dL at the time of random allocation
• Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Exclusion Criteria:
• Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
• Decline blood transfusion
• Scheduled for cardiac surgery during the current admission
• Receiving only palliative treatment
• Known that follow-up will not be possible at 30 days
• Previously participated in MINT
• Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
• Patient physician does not believe the patient is an appropriate candidate for the trial
Biological: Red Blood Cell Transfusion
Myocardial Infarction, Anemia
Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
SynCardia 70cc TAH-t for Destination Therapy (DT) (RA-540)
Judy Skroback, CIP, CRCP - jskroback@syncardia.com
Medalion, Benjamin
NCT02232659
HM20004553
Primary Arm
• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ? 1.7m2
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) Secondary Arm
• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
• Patients who are less than 19 years old
• Cardiac transplant-eligible patients
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with insufficient space in the chest
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Inclusion Criteria:
• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ? 1.7m2
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) Secondary Arm
Inclusion Criteria:
• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
• Patients who are less than 19 years old
• Cardiac transplant-eligible patients
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with insufficient space in the chest
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Device: 70cc TAH-t for Destination Therapy
Life-threatening, Biventricular Heart Failure, Ineligible for Cardiac Transplant
SynCardia, Total Artificial Heart, Biventricular heart failure, Ineligible for cardiac transplant
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Elizabeth Fosberg, B.A. - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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
Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS) (MAAIS)
Lisa Datta, MS - ibd@jhu.edu
Kuemmerle, John, F
NCT01169194
HM12998
Inclusion Criteria:
• African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)
• African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes
Exclusion Criteria:
Patients whose IBD cannot be confirmed
Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, IBD, CD, UC, IC, African American IBD, African American CD, African American UC, African American IC, Black IBD, Black CD, Black UC, Black IC, African American Inflammatory Bowel Disease, African American Crohn's Disease, African American Ulcerative Colitis, African American Indeterminate Colitis, Black Inflammatory Bowel Disease, Black Crohn's Disease, Black Ulcerative Colitis, Black Indeterminate Colitis
Project: Every Child for Younger Patients With Cancer (EVERYCHILD)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT02402244
HM20006485
Inclusion Criteria:
* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
* All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
* All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
* All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant
* The following other benign/borderline conditions:
* Mesoblastic nephroma
* Teratomas (mature and immature types)
* Myeloproliferative diseases including transient myeloproliferative disease
* Langerhans cell histiocytosis
* Lymphoproliferative diseases
* Desmoid tumors
* Gonadal stromal cell tumors
* Neuroendocrine tumors including pheochromocytoma
* Melanocytic tumors, except clearly benign nevi
* Ganglioneuromas
* Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit
* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
* If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1 OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
Pathway to Prevention Study
Memoli, Erica, H - erica.memoli@vcuhealth.org
Nelson, Bryce
NCT00097292
HM20012389
Endocrine, Nutritional And Metabolic Diseases, And Immunity Disorders, Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
Change in Vaginal Length & Sexual Function in Women Who Undergo Surgery ? RT for Endometrial Cancer
Dodson, Patricia, RN, BSN, CCRC - pwdodson@vcu.edu
Dodson, Patricia, RN, BSN, CCRC
10921
HM20004634
Modality: Radiotherapy
Corpus Uteri
Study of the Natural History of HCC and its Diagnostic, Prognostic Variables and Treatment Outcomes
Lee, Hannah, M. - hannah.lee@vcuhealth.org
Lee, Hannah, M.
12587
HM20007405
Liver
Radiotherapy for Early Stage Palmar and Plantar Fibromatosis
Loyall, Pamela - ployall@vcu.edu
Weiss, Elisabeth
10906
HM14042
Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Benotsch, Eric, G - ebenotsch@vcu.edu
Benotsch, Eric, G
13748
HM20011245
Detection of Urinary Bladder Cancer Using Raman Spectroscopy-Based Screening of Urine
Guruli, Georgi - georgi.guruli@vcuhealth.org
Guruli, Georgi
12588
HM20006879
Other Urinary, Bladder, Unknown Sites, Kidney, Prostate, Urinary Bladder
Molecular Characterization of Lung Tumors
Deb, Sumitra - sdeb@vcu.edu
Deb, Sumitra
11995
HM20006524
Lung
Southern Virginia Living Well Research and Registry (VLWR)
Thomson, Maria - mthomson2@vcu.edu
Sheppard, Vanessa, B.
14020
HM20012418
Any Site
Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits after Spinal Cord Injury
Amos, Tiffany - tiffany.amos@vcuhealth.org
Carter, William, E
NCT02660073
HM20005018
Cardiac Sarcoidosis Randomized Trial (CHASM-CS-RCT)
David H Birnie, MD - dbirnie@ottawaheart.ca
Kron, Jordana
NCT03593759
HM20014180
Inclusion Criteria:
(i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:
* advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
* significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
* non- sustained or sustained ventricular arrhythmia
* left ventricular dysfunction (LVEF \< 50%)
* right ventricular dysfunction (RVEF \< 40%)
AND
(ii) No alternative explanation for clinical features
AND
(iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging
AND ONE OR BOTH OF FOLLOWING
(iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac)
(v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy
Exclusion Criteria:
• Current or recent (within two months) non-topical treatment for sarcoidosis
• Current Oral/IV treatment of duration greater than 5 days
• Currently taking Methotrexate or Prednisone for another health condition
• Intolerance or contra-indication to Methotrexate or Prednisone
• Patient does not meet all of the above listed inclusion criteria
• Patient is unable or unwilling to provide informed consent
• Patient is included in another randomized clinical trial
• Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
• Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
• Breastfeeding
• Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
• Patients for whom the investigator believes that the trial is not in the interest of the patient
DRUG: Prednisone or Prednisolone, DRUG: Methotrexate
Cardiac Sarcoidosis, Sarcoidosis
Cardiac Sarcoidosis, Prednisone (or Prednisolone), Methotrexate
An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis
Wohlford, George, F - wohlfordgf@vcu.edu
Abbate, Antonio
14162
HM20014065
drug: Kpl-914
Diseases of Circulatory System (390-459)
Alinity i STAT hsTnI Design Validation Protocol
Ande, Michal - michal.ande@vcuhealth.org
Bachmann, Lorin, M
14400
HM20014754
Diseases of Circulatory System (390-459)
FSHD Longitudinal Biomarker Preparatory Study
Diaz, Liz, N - Liz.Diaz@vcuhealth.org
Johnson, Nicholas, E
14497
HM20015068
Diseases of Nervous System and Sense Organs (320-389)
Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients with Brain Cancer
Hess, Alison - ahess2@vcu.edu
Chen, Zhi-Jian
NCT03423628
HM20012958
Modality: Chemotherapy (nos), Modality: Radiotherapy
Brain and Nervous System
OKRA STUDY (OKRA)
Ruddley, Joyce, R - joyce.ruddley@vcuhealth.org
Kumar, Dhiren
NCT03326076
HM20012716
KOAR
• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Inclusion Criteria:
• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
Exclusion Criteria:
___________________________________________________________
Exclusions for AlloSure? Intended Use
Specimens from patients for whom any of the following are true will not be tested:
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Diagnostic Test: Donor-derived cell-free DNA (AlloSure?), Other: Standard care, Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)
Kidney Transplant Rejection
Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1
Howell, Jodie - jodie.howell@vcuhealth.org
Johnson, Nicholas, E
14536
HM20014419
Diseases of Musculoskeletal System and Connective Tissue (710-739), Diseases of Musculoskeletal System and Connective Tissue (710-739), Diseases of Musculoskeletal System and Connective Tissue (710-739)
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (TRANSCEND )
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
McCarty, John, M.
NCT03331198
HM20016147
Inclusion Criteria:
* Diagnosis of:
• CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
• SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL) * Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy. * Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
• Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
• Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
• DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i. * Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:
• be receiving ibrutinib and progressing at the time of study enrollment
• be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
• have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
• have previously received ibrutinib and have no contraindications to restarting ibrutinib * Eastern Cooperative Oncology Group performance status of ≤ 1 * Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy * Adequate organ function, defined as:
• Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance \> 30 mL/min
• Alanine aminotransferase ≤ 5 × ULN and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
• Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
• Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility * Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure. * If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy. * Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax * Subjects in venetoclax + JCAR017 combination cohort must:
• have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
• be venetoclax naive (required for dose expansion) or
• if prior venetoclax (only for dose escalation)
• have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation * subjects in the venetoclax + JCAR017 combination must have hemoglobin \>=9 g/dL, absolute neutrophil count \>=500mm3 and platelets\>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow * must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry
Exclusion Criteria:
* Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
* History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
* Subjects with Richter's transformation
* Prior treatment with any gene therapy product
* Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Presence of acute or extensive chronic graft versus host disease (GVHD)
* History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
* History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
* Pregnant or nursing (lactating) women
* Use of any of the following medications or treatments within the noted time prior to leukapheresis:
• Alemtuzumab within 6 months prior to leukapheresis
• Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
• Cladribine within 3 months prior to leukapheresis
• Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
• Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
• Fludarabine within 4 weeks prior to leukapheresis
• GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α \[TNFα\], anti-interleukin-6 \[IL-6\], or anti-interleukin-6 receptor \[IL 6R\]) within 4 weeks prior to leukapheresis
• Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
• Therapeutic doses of corticosteroids (defined as \> 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
• Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
• Venetoclax within 4 days prior to leukapheresis
• Idelalisib or duvelisib within 2 days prior to leukapheresis
• Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis
• Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis * Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol * Progressive vascular tumor invasion, thrombosis, or embolism * Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation * Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis. * Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation * For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued
BIOLOGICAL: JCAR017 (lisocabtagene maraleucel), BIOLOGICAL: JCAR017 (lisocabtagene maraleucel) + ibrutinib, BIOLOGICAL: JCAR017 (lisocabtagene maraleucel) + venetoclax
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Small Lymphocytic
TRANSCEND_CLL_004
Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction
Rebecca Collen, MBA - rebecca.collen@vcuhealth.org
Yajnik, Vishal
NCT03947671
HM20015426
Inclusion Criteria:
• scheduled coronary artery bypass graft surgery patients, with or without valve surgery
• patients able to give informed consent
Exclusion Criteria:
• age < 20 years or > 89 years
• patients with unscheduled CABG +/- valve surgery (i.e. emergency surgery)
• deformity or skin condition of chest or thighs that would interfere with the successful placement of Rapr Round® vest and leg wraps
• patients presenting to the ICU postoperatively with a fever ≥ 38.3
• patients with planned intraoperative circulatory arrest
• prisoners
• pregnant patients
• patients with symptomatic cerebrovascular disease, specifically residual motor deficits, expressive or receptive aphasia from prior stroke or cerebrovascular accident
Device: Rapr Rounds Hyper/Hypothermia Wraps, Drug: Acetaminophen
Cardiac Surgery, Post-operative Cognitive Dysfunction, Fever
temperature regulation
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com
McCarty, John, M.
NCT03435796
Inclusion Criteria:
• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
• Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
Not Applicable
Other protocol-defined inclusion/exclusion criteria apply
Genetic: Gene-modified (GM) T cell therapy
Neoplasms
Long-term follow up, Gene-Modified T Cells, CAR T Cell
Effects of a Mindfulness Intervention in Caregivers of People With Dementia (CARING) (CARING)
Dzierzewski, Jospeh - dzierzewski@vcu.edu
Dzierzewski, Jospeh
NCT03857308
HM20011802
Inclusion Criteria:
• English speaking
• Self-reporting informal caregivers of persons with dementia
Exclusion Criteria:
• Self-reported major depressive disorder with psychotic features
• History of schizophrenia
• Bipolar disorder
• Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
• Previous MBSR training or regular meditative practice within previous 6 months
Behavioral: Mindfulness Training, Behavioral: Reappraisal Training
Caregivers, Burnout, Sleep
well-being, sleep, caregiver
Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
Jennifer Raymond - jennifer.raymond@vcuhealth.org
Johnson, Nicholas, E
NCT03981575
HM20014419
Inclusion criteria:
* Age 18 to 70 (inclusive)
* Competent to provide informed consent
* Clinical diagnosis of DM1 based on research criteria1 or positive genetic test
* Comment: The clinical research criteria require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in \> 99% of individuals who satisfied these criteria.2
Exclusion criteria:
* Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than skin cancer.
* Current alcohol or substance abuse
* Concurrent enrollment in clinical trial for DM1, or participation in trial within 6 months of entry.
* Concurrent pregnancy or planned pregnancy during the course of the study.
* Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator, compromise performance on study measures.
* Note: non-ambulatory participants are not excluded, but are limited to \<15% of enrollment.
Inclusion criteria for participants in the muscle biopsy sub-study:
• Of the 95 patients undergoing the tibialis anterior muscle biopsy, at least half will have at least moderate weakness of ankle dorsiflexion, defined as MRC score ≤ 4+. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy. Approximately 10 patients at each site will undergo the muscle biopsy.
Exclusion criteria for 95 participants in the muscle biopsy sub-study:
* Known CTG repeat expansion size less than 100 repeats, unless there are clear cut signs of limb weakness and muscle wasting. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy.
* Use of anticoagulant such as warfarin or a direct oral anticoagulant (e.g. dabigatran) due to the increased risk of bleeding.
* Use of aspirin or non-steroidal anti-inflammatory agents should be discontinued 3 days prior to the biopsy procedure, if possible.
* Platelet count \<50,000 (if known) due to the increased risk of bleeding.
* History of a bleeding disorder due to the increased risk of bleeding.
* Advanced wasting of tibialis anterior (TA) muscle that precludes needle muscle biopsy in order to ensure that a sample taken would be of muscle and not just fat and fascia.
* Previous muscle biopsy of either TA in order to provide muscle tissue samples of non-biopsied muscles.
Myotonic Dystrophy 1, DM1
Myotonic Dystrophy, END DM-1, Muscular Dystophy, DMCRN
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Franco, Robert, "Lee" - francorl@vcu.edu
Franco, Robert, "Lee"
NCT03958734
HM20015510
Inclusion Criteria:
• college-age: 18-30 years old
• normal fasting triglyceride (<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).
• normal body composition: % body fat, males <25%, females <32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)
• self-reported engagement in moderate-vigorous intensity physical activity and/or an exercise training regimen OR self-reported low physical activity and no engagement in an exercise training regimen (International Physical Activity Questionnaire)
• low cardiorespiratory fitness (VO2peak; male: =<45 mL/kg/min; female: =<35 mL/kg/min; categorized as =40th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) OR high cardiorespiratory fitness (VO2peak; male: =55 mL/kg/min; female: 45 mL/kg/min; categorized as =70th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) f.) for female participants, presence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods. .
Exclusion Criteria:
• presence of diagnosed cardiovascular, metabolic, or renal disease or dysfunction
• presence of signs and symptoms suggestive of cardiovascular, metabolic, or renal disease
• presence of musculoskeletal injury
• pregnancy
• history of smoking
• engagement in an abnormal eating behavior
• unable to communicate effectively in English
• moderate cardiorespiratory fitness (VO2peak; male: 46-54 mL/kg/min; female: 36-44 mL/kg/min)
• elevated or high fasting triglycerides (>150 mg/dL)
• absence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods
Other: High-fat meal
Cardiovascular Risk Factor, Lipemia, Diseases of Circulatory System (390-459)
Vascular Dysfunction
Neuroblastoma Maintenance Therapy Trial (NMTT)
BCC Enroll - BCCEnroll@pennstatehealth.psu.edu
Gowda, Madhu, S
NCT02679144
HM20015342
Inclusion Criteria:
* All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.
* All patients must be in complete remission (CR):
• No evidence of residual disease on scan
• No evidence of disease metastatic to bone marrow. * Specific Criteria by Stratum: Stratum 1/1B: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1/B must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s). * Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed: * Tumor imaging studies including * Bilateral bone marrow aspirates and biopsy * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment. * Timing from prior therapy: Stratum 1/1B: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent therapy. * Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months. * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below. * Patients must have adequate organ functions at the time of registration: * Hematological: Total absolute phagocyte count ≥1000/μL * Liver: Subjects must have adequate liver function * Renal: Adequate renal function * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding. * Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
Exclusion Criteria:
* BSA (Body Surface Area) of \<0.25 m2.
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. DRUG: Difluoromethylornithine (DFMO)
Neuroblastoma