Study on Acalabrutinib and Liso-Cel for Treating Relapsed or Refractory Aggressive B-Cell Lymphomas

Sponsor: Patrick C. Johnson, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05583149

Provider View

This clinical trial is testing the combination of acalabrutinib and lisocabtagene maraleucel (liso-cel) to see if it is safe and effective for people with aggressive B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining acalabrutinib with lisocabtagene maraleucel (liso-cel) for treating aggressive B-cell lymphoma that has either come back or not responded to earlier treatments. Participants will receive one infusion of liso-cel and take acalabrutinib capsules twice daily for up to one year, as long as the treatment is tolerated and the disease does not worsen. The study will involve regular follow-up visits for up to 5 years, and medical records will be monitored for up to 15 years. Approximately 27 people are expected to participate in this Phase II clinical trial, which aims to test the safety and effectiveness of this investigational treatment. While acalabrutinib is not yet approved by the FDA for this specific use, lisocabtagene maraleucel is approved for this disease. The study is supported by AstraZeneca, which provides funding and supplies acalabrutinib.

Description

This study involves testing a combination of two treatments: acalabrutinib and lisocabtagene maraleucel (liso-cel). Participants will undergo screening to determine eligibility and will receive the study treatment, which includes evaluations and follow-up visits. Participants will receive one infusion of liso-cel and take acalabrutinib capsules twice daily for up to one year, as long as the treatment is tolerated and the disease does not worsen. Participants will be monitored through clinical visits for up to 5 years, and their medical records will be checked for up to 15 years. The study is a Phase II clinical trial, which means it is testing the safety and effectiveness of the treatment to see if it works for treating aggressive B-cell lymphoma. The FDA has approved lisocabtagene maraleucel for this disease, but acalabrutinib is still being studied for this specific use. AstraZeneca is supporting the study by providing funding and the acalabrutinib medication.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed aggressive B-cell lymphoma, including specific subtypes like diffuse large B-cell lymphoma (DLBCL) and others.
  • The cancer must have returned or not responded to at least two previous treatments, including a CD20-targeted agent and an anthracycline or alkylating agent.
  • Must have PET-positive measurable disease.
  • Must have an ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have adequate kidney function with creatinine clearance of at least 30 mL/min.
  • Liver function tests must be within specified limits.
  • Must have stable heart function with a left ventricle ejection fraction of at least 40%.
  • Must have controlled and asymptomatic atrial fibrillation if present.
  • Must have adequate blood counts, including neutrophils and platelets.
  • Must have adequate lung function and oxygen levels.
  • Must have suitable vascular access for a leukapheresis procedure.
  • Women of childbearing potential must use effective contraception during treatment and for 2 days after the last dose of acalabrutinib.
  • Must be willing and able to participate in all required evaluations and procedures.
  • Must understand the study and provide informed consent.

Exclusion Criteria

  • Have another active cancer requiring treatment.
  • Have had previous gene therapy or adoptive T cell therapy.
  • Have had an allogeneic stem cell transplant within 90 days of leukapheresis.
  • Have active graft-versus-host disease (GVHD).
  • Have HIV infection.
  • Have active hepatitis B or C infection.
  • Have an uncontrolled infection.
  • Have significant central nervous system issues.
  • Have had serious heart conditions in the past 6 months.
  • Require chronic high-dose corticosteroids for autoimmune disease.
  • Have had certain treatments like alemtuzumab, fludarabine, or cladribine recently.
  • Require therapeutic anticoagulation.
  • Have a bleeding disorder.
  • Have difficulty swallowing or absorbing oral medication.
  • Have a known allergy to the study drugs.
  • Have a recent gastrointestinal ulcer.
  • Require treatment with certain strong medications that affect drug metabolism.
  • Have a history of significant stroke or brain bleeding recently.
  • Have had major surgery recently.
  • Are pregnant or breastfeeding.

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