Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- 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
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: 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 hour...
OUTLINE: 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.
Tracking Information
- NCT #
- NCT04257578
- Collaborators
- National Cancer Institute (NCI)
- AstraZeneca
- Investigators
- Principal Investigator: Ajay Gopal Fred Hutch/University of Washington Cancer Consortium