Acalabrutinib + CAR T-cell Therapy for B-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot use strong CYP3A inhibitors or inducers within 7 days of starting the study drugs. If you are on a proton pump inhibitor, you may need to switch to a different type of medication.
What data supports the effectiveness of the treatment Acalabrutinib + CAR T-cell Therapy for B-Cell Lymphoma?
Axicabtagene ciloleucel, a component of the treatment, has shown high response rates and a manageable safety profile in patients with relapsed or refractory B-cell malignancies, including large B-cell lymphoma, and is approved by the FDA for such conditions. In a study, it achieved a 78% complete response rate as part of first-line therapy for high-risk large B-cell lymphoma.12345
What safety data exists for Acalabrutinib + CAR T-cell Therapy in humans?
Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy, has been studied for B-cell lymphoma and shows a manageable safety profile. Common side effects include cytokine release syndrome (a condition where the immune system is overly activated) and neurological events, but severe cases are less common. No treatment-related deaths were reported in the studies reviewed.13678
How is the treatment Acalabrutinib + CAR T-cell Therapy different for B-Cell Lymphoma?
This treatment combines Acalabrutinib, a drug that targets specific proteins in cancer cells, with Axicabtagene Ciloleucel, a CAR T-cell therapy that uses modified immune cells to attack cancer. This combination is unique because it targets the cancer in two different ways, potentially improving effectiveness for patients with relapsed or refractory B-cell lymphoma who have limited treatment options.125910
Research Team
Ajay K. Gopal
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
Adults with B-cell lymphoma eligible for axi-cel per FDA, understanding and consenting to the study, ECOG status of 0-1, adequate organ function, no active infections or second cancers needing treatment. Excludes those intolerant to acalabrutinib, with brain metastases or cerebrospinal fluid malignant cells, on strong CYP3A inhibitors/inducers, refractory to BTK inhibition, low blood counts, pregnant/breastfeeding women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acalabrutinib orally every 12 hours and axicabtagene ciloleucel intravenously after lymphodepleting chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Acalabrutinib
- Axicabtagene Ciloleucel
Acalabrutinib is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from รcole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from รcole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology