Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma (NCT05256641) | Clinical Trial Compass
RecruitingPhase 1/2
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma
United States24 participantsStarted 2023-01-23
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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…