Study on Acalabrutinib and CAR T-cell Therapy for Treating B-cell Lymphoma

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT04257578

Provider View

This clinical trial is testing a combination of acalabrutinib and CAR T-cell therapy to see if it is safe and effective in treating patients with B-cell lymphoma. Acalabrutinib may help stop cancer cell growth, and CAR T-cell therapy is designed to target and destroy lymphoma cells.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of using acalabrutinib together with axicabtagene ciloleucel, a type of CAR T-cell therapy, in patients with B-cell lymphoma. Acalabrutinib may help block pathways that cancer cells need to grow, while axicabtagene ciloleucel is engineered to target specific markers on lymphoma cells. The combination aims to enhance the treatment's ability to fight B-cell lymphoma.

Description

In this study, patients will start taking acalabrutinib by mouth every 12 hours up to 3 weeks before a procedure called leukapheresis, which collects white blood cells. This treatment will continue unless the disease worsens or side effects become unacceptable. After receiving chemotherapy to prepare the body, patients will receive axicabtagene ciloleucel through an IV. After completing the study treatment, patients will have follow-up visits every 3 months for up to 5 years to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of B-cell lymphoma, such as diffuse large B-cell lymphoma or follicular lymphoma.
  • Eligible to receive commercial axi-cel treatment as per FDA guidelines.
  • Aged 18 years or older.
  • Able to understand and sign a written consent form.
  • Women of childbearing potential must have a negative pregnancy test before starting acalabrutinib.
  • Both men and women must agree to use effective birth control during and for at least 4 months after treatment.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate kidney and liver function as indicated by specific blood tests.
  • Good lung function with oxygen levels at or above 92% on room air.
  • Heart function must be sufficient, with a pumping ability of at least 50%.
  • At least one measurable tumor lesion.
  • For HIV-positive patients: must have controlled HIV with a low viral load and a CD4 count above 200 cells/mm3.
  • HIV-positive patients must be on stable anti-retroviral therapy for more than 4 weeks before starting the study drug.
  • No active opportunistic infections or uncontrolled systemic infections.
  • Hemoglobin levels above 8.0 g/dl for HIV-positive patients.
  • Adequate kidney function for HIV-positive patients.

Exclusion Criteria

  • Active or uncontrolled infections that would interfere with treatment.
  • Intolerance to acalabrutinib.
  • Need for certain stomach medications that cannot be switched.
  • Cancer spread to the brain or spinal fluid.
  • History of seizures, strokes, or certain brain diseases.
  • Use of certain medications that affect the study drugs within 7 days of starting treatment.
  • Cancer that does not respond to BTK inhibitors.
  • Low blood cell counts below specified levels.
  • Another active cancer requiring treatment, unless approved by the study leader.
  • Significant heart disease or recent heart attack.
  • Difficulty swallowing pills or digestive issues affecting medication absorption.
  • Active bleeding disorders.
  • Uncontrolled autoimmune blood disorders.
  • Use of certain blood thinners within 7 days of starting treatment.
  • Recent major surgery within 7 days of starting treatment.
  • Active hepatitis B or C infections.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.