Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04257578|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : December 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Non-Hodgkin Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma Primary Mediastinal (Thymic) Large B-Cell Lymphoma Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma||Drug: Acalabrutinib Biological: Axicabtagene Ciloleucel||Phase 1 Phase 2|
Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib orally (PO) every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel intravenously (IV) at 36-96 hours after completion of lymphodepleting chemotherapy.
After completion of study treatment, patients are followed up every 3 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acalabrutinib in Combination With Anti-CD19 Chimeric Antigen Receptor T-Cells (CART) in B-Cell Lymphoma|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2029|
Experimental: Treatment (acalabrutinib, axicabtagene ciloleucel)
Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy.
Biological: Axicabtagene Ciloleucel
- Incidence of adverse events [ Time Frame: Up to 30 days post axicabtagene ciloleucel infusion ]Toxicity as defined by the following: grade >= 3 cytokine release syndrome, grade >= 3 neurotoxicity within 30 days of infusion of axicabtagene ciloleucel. Grading will be done in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for neurotoxicity and the Lee Criteria for cytokine release syndrome, unless otherwise specified.
- Complete response rate following chimeric antigen receptor T-cells therapy (CART) [ Time Frame: Up to 5 years post treatment ]Will be assessed per Lugano criteria.
- Overall survival [ Time Frame: Up to 5 years post treatment ]
- Progression-free survival [ Time Frame: Up to 5 years post treatment ]
- Response rate [ Time Frame: Up to 3 weeks ]Will assess response rate (complete response + partial response + stable response) following bridging prior to CART.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257578
|Contact: Ajay Gopalemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay Gopal 206-606-2307 firstname.lastname@example.org|
|Principal Investigator: Ajay Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|