Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy
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.
• Men and women \>= 18 years of age
• Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified \[DLBCL NOS\], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =\< 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry
• Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at day 30 +/- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)
• Documented measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United \[ACCRU\] web site under Study Resources -\> Forms)
• Absolute neutrophil count (ANC) \>= 1,000/mm\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\< 14 days prior to registration)
• Platelet count \>= 50,000/mm\^3 (obtained =\< 14 days prior to registration)
• Hemoglobin \>= 7.0 g/dL if asymptomatic or hemoglobin \> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\< 14 days prior to registration)
⁃ NOTE: symptoms include shortness of breath, fatigue, lightheadedness
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is =\< 5 x ULN (obtained =\< 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (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)
⁃ NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the Lab Test Unit Conversion Worksheet available on the ACCRU website under General Forms.
• 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:
∙ Has not undergone a hysterectomy or bilateral oophorectomy; or
‣ Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Provide informed written consent =\< 28 days prior to registration
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment and clinical follow-up)
• Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes