Acalabrutinib Maintenance Following Cellular Therapy for Large B-Cell Lymphoma Patients at Very High Risk for Relapse
This phase Ib/II trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.
• Ages 18-70 years
• One of the following:
‣ Patients undergoing autologous stem cell transplantation (ASCT) or any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product for:
• High grade B-cell lymphoma (double or triple hit) with rearrangements in bcl-2 and/or bcl-6, and rearrangement in myc
∙ Large B-cell lymphoma with a history of secondary CNS involvement
∙ Histologic transformation of indolent lymphoma to large B-cell lymphoma, including marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), lymphoplasmacytic leukemia, or Waldenstrom macroglobulinemia
∙ High risk international prognostic index (IPI) score 4 or 5, at diagnosis or prior to CAR T-cell leukapheresis
⁃ Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Requirements for post-ASCT and post-alloHCT participants:
‣ Disease status of partial response (PR) or complete response (CR) prior to transplantation
⁃ Receive reduced-intensity conditioning regimen
⁃ Enrollment no later than day +90
• Requirements for post-CAR T-cell therapy participants:
‣ Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months
⁃ Enrollment no later than day +104
• Ability to give full informed consent
• Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib
• Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty
• Absolute neutrophil count (ANC) \> 500/uL (microliters)
• Platelets \> 50,000/uL independent of transfusions
• Hemoglobin \> 8 g/dL independent of transfusions
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
• Total bilirubin =\< 1.5 x ULN, unless directly attributable to Gilbert's syndrome
• Creatinine clearance \>= 60 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =\< 1.8 mg/dL