StudyFinder
Search Results Within Category "Cancer"
Suggestions within category "Cancer"
94 Study Matches
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
Jayke Giese - leukemiaprotocols@alliancenctn.org
NCT07321652
Inclusion Criteria:
* STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility
* STEP 0: Patients must be diagnosed with CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:
* ≥ 5 x10\^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)
* On morphologic review, the leukemic cells must be small mature lymphocytes
* Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \> 10% of cells must lack t(11;14) translocation by interphase cytogenetics
* STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:
* Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \< 10 g/dL, platelet count \< 100,000/mm\^3
* Massive (\> 6 cm below the costal margin), progressive or symptomatic splenomegaly
* Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
* Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
* Constitutional symptoms, which include any of the following:
* Unintentional weight loss of ≥ 10% within the previous 6 months
* Significant fatigue (ie. Eastern Cooperative Oncology Group \[ECOG\] performance status \[PS\] ≥ 2)
* Fevers \>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection
* Night sweats \> 1 month without evidence of infection
* STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
* STEP 0: Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
* STEP 0: Age ≥ 65 years
* STEP 0: ECOG performance status ≤ 2
* STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment
* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better.
Patients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment
* STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage
* STEP 0: No patients with known active progressive central nervous system (CNS) disease
* STEP 0: No known medical condition causing an inability to swallow oral formulations of agents
* STEP 1: The adaptive report confirming a measurable and trackable B cell clone
* STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician
* STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document
* STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
* STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
* STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4/5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug
* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mm3 unless due to marrow involvement
* STEP 1: Platelet count ≥ 30,000/mm3
* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)
* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver
* STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL/min
* STEP 1: Urine protein to creatinine ratio \< 1 or urine protein ≤ 1+
* STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ
* STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy DRUG: Zanubrutinib, DRUG: Sonrotoclax, PROCEDURE: Computed Tomography, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Biospecimen Collection, OTHER: Survey Administration
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial (STEPS-BC)
Karen Craver, MT, MHA - NCORP@wfusm.edu
NCT07474090
Inclusion Criteria:
* Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received ≥ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable
* Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy
* Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group
* Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report
* Able to hold breath for 8 seconds
* Must be able to read and understand English language
* Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program
* Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program
* Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed
Exclusion Criteria:
* At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):
* Symptomatic claustrophobia
* Pregnancy or breast-feeding
* Ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders
* Uncontrolled hypertension (systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 100 mm Hg)
* Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician
* Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/min)
* Atrial fibrillation with uncontrolled ventricular response (\> 130 beats per minute \[bpm\])
* Unstable or stable angina (cardiac chest pain)
* Severe pulmonary hypertension
* Left main coronary artery disease
* Symptomatic heart failure
* Severe valvular heart disease
* Aortic aneurysm (\> 45 mm diameter) or aortic dissection
* Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
* Hypertrophic obstructive cardiomyopathy
* Acute myocardial infarction within 28 days of enrollment
* Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment
* Plans to relocate within 6 months of enrollment and unable to participate in study procedures
* May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial
* May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior)
* May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination OTHER: Exercise Intervention, OTHER: Educational Intervention, OTHER: Supportive Care, PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Magnetic Resonance Imaging, OTHER: Questionnaire Administration, PROCEDURE: Accelerometry, OTHER: Electronic Health Record Review, OTHER: Cardiopulmonary Exercise Testing
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma, Breast Inflammatory Carcinoma, Locally Recurrent Breast Carcinoma
A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer (FLORENZA)
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT07059845
Inclusion Criteria:
Substudy 1
* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.
* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.
Substudy 2
* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
Substudy 3
* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
Exclusion Criteria:
Substudy 1
* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).
Substudy 2
* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
* Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
* Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
* If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
* Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
Substudy 3
* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
* Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
* Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
* If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
* Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents. DRUG: Mirvetuximab Soravtansine, DRUG: Bevacizumab, DRUG: Carboplatin
Ovarian Cancer
Ovarian Cancer, Mirvetuximab Soravtansine, Bevacizumab, Carboplatin
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT06989437
Key inclusion Criteria:
* Signed Informed Consent Document
* Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
* Cachexia defined by Fearon criteria of weight loss
* Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
* ECOG PS ≤1 with life expectancy of at least 4 months
Key
Exclusion Criteria:
* Current active reversible causes of decreased food intake
* Cachexia caused by other reasons
* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
* Left ventricular ejection fraction \<50%
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
* Inadequate liver function
* Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2 DRUG: ponsegromab, DRUG: placebo
Cachexia, Metastatic Pancreatic Ductal Adenocarcinoma
pancreatic cancer, metastatic cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue