Tests acalabrutinib after cell therapy in adults with large B-cell lymphoma

Trial details

Who runs it

Jonsson Comprehensive Cancer Center

Trial code

NCT05256641

Record updated

10 March 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication; Received packed red blood cells (pRBC) transfusion within the past 2 weeks; Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug; Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug; Refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment; Received a live virus vaccination within 28 days of first dose of study drug; Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists; Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited; Concurrent participation in another therapeutic clinical trial; New York Heart Association Class III or IV; Acute or chronic graft-versus-host disease (GvHD) >= stage 3 at time of enrollment; Active invasive fungal infection; Active bacterial or viral infection until resolution of the infection; History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML); Known history of infection with human immunodeficiency virus (HIV); History of bleeding diathesis (e.g., hemophilia, von Willebrand disease); Left ventricular ejection fraction < 50%; Received platelet transfusion within the past 1 week; Cord blood as donor source in alloHCT; Estimated glomerular filtration rate < 30 mL/min; Breastfeeding or pregnant.

ClinicalTrials.gov NCT05256641