Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL post-1L Finite cBTKi+BCL2i ± Obinutuzumab - MAVRiC
Study identifier:D8220C00036
ClinicalTrials.gov identifier:NCT07024706
EudraCT identifier:N/A
CTIS identifier:2024-518858
Will Be Recruiting
Official Title
The MAVRiC Study: A Phase II Study of Disease Risk Mutation guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab
Medical condition
Chronic Lymphocytic Leukemia (CLL)
Phase
Phase 2
Healthy volunteers
No
Study drug
Acalabrutinib, Venetoclax
Sex
All
Estimated Enrollment
80
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 30 Sept 2025
Estimated Primary Completion Date: 30 Nov 2032
Estimated Study Completion Date: 30 Nov 2032
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
AbbVie Inc, Genentech, Inc
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Acalabrutinib and Venetoclax For Cohort 1, each participant will be in the study for approximately 5 years (60 months) counting from C1D1, starting with 2 cycles of acalabrutinib lead-in treatment, followed by 12 cycles of AV combination treatment, and 4 years of follow‑up. For Cohort 2, each participant will be in the study for approximately 5 years (60 months) counting from C1D1 starting with 2 cycles of acalabrutinib lead‑in treatment, followed by 22 cycles of AV combination treatment, and 3 years of follow-up. | Drug: Acalabrutinib Acalabrutinib is an orally available cBTKi that inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. Other Name: CALQUENCE® Drug: Venetoclax Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2 Other Name: Venclexta® Other Name: Venclyxto® |
Drug: Acalabrutinib Acalabrutinib is an orally available cBTKi that inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. Other Name: CALQUENCE® Drug: Venetoclax Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2 Other Name: Venclexta® Other Name: Venclyxto® |
