A Phase 2 interventional study of Biopsy and Biospecimen Collection in Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-Cell Lymphoma and Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, sponsored by Academic and Community Cancer Research United. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment
This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.
PRIMARY OBJECTIVE:
I. To compare complete response (CR) rate using the Lugano 2014 criteria for patients receiving epcoritamab versus observation alone in patients with aggressive B-cell lymphomas who achieved partial response (PR) post CAR-T therapy.
SECONDARY OBJECTIVES:
I. To compare the progression free survival (PFS) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
II. To compare event free survival (EFS) in patients who receive epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
III. To compare the overall survival (OS) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
IV. To compare the duration of response (DOR) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
V. To compare the duration of complete response (DoCR) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
VI. To compare the time to response (TTR) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
VII. To compare the objective response rate (ORR) of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T.
VIII. To assess the safety and tolerability of epcoritamab post CAR-T in patients with aggressive B-cell lymphomas.
EXPLORATORY OBJECTIVE:
I. To assess outcomes based on CAR-T line of therapy and costimulatory domain of CAR-T construct.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive epcoritamab subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and day 1 of cycles 10-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) at screening, undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.
ARM B: Patients undergo observation per standard care. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.
After completion of study treatment, patients are followed up every 90 days for 1 year and then every 180 days for up to 5 years post-registration.
Hemoglobin >= 7.0 g/dL if asymptomatic or hemoglobin > 8 if symptomatic; transfusion support allowed, if necessary (obtained =\< 14 days prior to registration)
Calculated creatinine clearance must be >= 45 mL/min using the Crockcroft- Gault formula (obtained =\< 14 days prior to registration)
Negative serum pregnancy test done =\< 7 days prior to registration for a woman of childbearing potential (WOCBP) only
NOTE: A WOCBP is a sexually mature female who:
Exclusion Criteria:
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown
Any of the following prior therapies:
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\< 14 days prior to registration, including COVID- 19 infection.
Patients receive epcoritamab SC on days 1, 8, 15, and 22 of cycles 1-3, days 1 and 15 of cycles 4-9, and day 1 of cycles 10-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.
Procedure: Biopsy · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Biological: Epcoritamab · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
Patients undergo observation per standard care. Patients also undergo MRI at screening, undergo PET/CT and collection of blood samples throughout the trial, and undergo biopsy at screening and end of treatment. Patients may undergo CT or MRI during follow up.
Procedure: Biopsy · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Other: Patient Observation · Procedure: Positron Emission Tomography
Undergo biopsy
Also known as: BIOPSY_TYPE, Bx
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo PET/CT and/or CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Given SC
Also known as: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, GEN-3013, GEN3013
Undergo MRI
Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo observation
Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Objective status of complete response (CR)
CR will be assessed using Lugano 2014 criteria. Complete response rate is defined as the number of patients who achieve objective status of CR divided by the total number patients in each arm. Primary analysis population will be used for this endpoint. The proportion of CR rate in each arm with corresponding confidence interval and p-value comparing the CR rate will be reported.
Time frame: From randomization up to one year
Progression free survival
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population will be used for this endpoint. The distribution of progression free survival will be estimated using the method of Kaplan-Meier. Progression free survival will be compared between the 2 treatment arms using the log-rank test. The median progression free survival and corresponding 95% confidence intervals will be reported.
Time frame: From randomization to documentation of disease progression or death, assessed up to 5 years post-registration
Event free survival
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population will be used for this endpoint. The distribution of event free survival will be estimated using the method of Kaplan-Meier. Event free survival will be compared between the 2 treatment arms using the log-rank test. The median event free survival and corresponding 95% confidence intervals will be reported.
Time frame: From randomization to documentation of disease progression, start of non-protocol lymphoma therapy, or death due to any cause, assessed up to 5 years post-registration
Overall survival
Primary analysis population will be used for this endpoint. The distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between the 2 treatment arms using the log-rank test. The median overall survival and corresponding 95% confidence intervals will be reported.
Time frame: From randomization to death due to any cause, assessed up to 5 years post-registration
Duration of response
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population achieving response of CR or PR will be used for this endpoint. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Duration of response will be compared between the 2 treatment arms using the log-rank test. The median duration of response and corresponding 95% confidence intervals will be reported.
Time frame: From first documentation of objective status of partial response (PR) or CR to documentation of disease progression, assessed up to 5 years post-registration
Duration of complete response
Disease progression will be defined by Lugano 2014 criteria. Primary analysis population achieving response of CR will be used for this endpoint. The distribution of duration of complete response will be estimated using the method of Kaplan-Meier. Duration of complete response will be compared between the 2 treatment arms using the log-rank test. The median duration of complete response and corresponding 95% confidence intervals will be reported.
Time frame: From first documentation of objective status of CR to documentation of disease progression, assessed up to 5 years post-registration
Time to response
Response will be defined by Lugano 2014 criteria. Primary analysis population achieving response of CR or PR will be used for this endpoint. The distribution of time to response will be estimated using descriptive statistics such as median and range. Time to response will be compared between the 2 treatment arms using the Wilcoxon-rank sum test.
Time frame: From randomization to the first documentation of objective status of PR or CR, assessed up to 5 years post-registration
Objective response rate (ORR)
Response will be defined by Lugano 2014 criteria. ORR is defined as the number of patients who experience objective response divided by the number of patients in primary analysis population. ORR will be compared between the 2 treatment arms. Confidence intervals for ORR will be calculated according to the approach of Clopper and Pearson. Overall response rate and the corresponding 95% confidence interval will be reported.
Time frame: From randomization up to one year
Incidence of adverse events
Primary analysis population will be used for adverse event analyses. The overall adverse event rates for grade 3 or higher adverse events will be reported. Further analysis of adverse event rates will be considered exploratory.
Time frame: Up to 1 year post-treatment
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Academic and Community Cancer Research United