Open Actively Recruiting

Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma


Brief 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.

Primary Purpose
Study Type
Phase 1/Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
70 Years

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 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 Criteria:

  • Cord blood as donor source in alloHCT
  • New York Heart Association Class III or IV
  • Left ventricular ejection fraction < 50%
  • Estimated glomerular filtration rate < 30 mL/min
  • Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication
  • Acute or chronic graft-versus-host disease (GvHD) >= stage 3 at time of enrollment
  • Received packed red blood cells (pRBC) transfusion within the past 2 weeks
  • Received platelet transfusion within the past 1 week
  • Active invasive fungal infection
  • Active bacterial or viral infection until resolution of the infection
  • History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
  • 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
  • Known history of infection with human immunodeficiency virus (HIV)
  • History of bleeding diathesis (e.g., hemophilia, von Willebrand disease)
  • 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
  • Breastfeeding or pregnant
  • Concurrent participation in another therapeutic clinical trial

Join this Trial

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Study Stats
Protocol No.
Caspian Oliai
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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