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

About

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
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
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.
21-000979
Category
Hematology-Oncology
Oncology
Contact
Caspian Oliai
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05256641
For detailed technical eligibility, visit ClinicalTrials.gov.