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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
This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.
The purpose of this study is to explore the use of second line (2L) treatment with AV after relapse following first line (1L) cBTKi + BCL2i by assessment of ORR in participants with CLL/SLL. This study will generate efficacy and safety data needed to understand outcomes associated with AV in patients who initially responded with partial remission (PR) or better for a minimum of 2 years from the end of 1L cBTKi + BCL2i combination treatment and are experiencing clinical relapse requiring further treatment. MAVRiC explores AV as second-line (2L) CLL/SLL treatment after relapse on first-line (1L) cBTKi + BCL-2 by assessment of overall response rate (ORR) * The study duration for each participant will be up to 5 year. * The study consists of screening, treatment, and post-intervention follow-up periods. * Participants will be grouped into low or high risk cohorts based on disease risk determined by IGHV mutation and TP53 aberrancy.
Age
18 - 130 years
Sex
ALL
Healthy Volunteers
No
Research Site
Boston, Massachusetts, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Horn, Austria
Research Site
Brno, Czechia
Research Site
Hradec Kralova, Czechia
Research Site
Ostrava, Czechia
Research Site
Dublin, Ireland
Research Site
Dublin, Ireland
Research Site
Lugo, Italy
Start Date
January 30, 2026
Primary Completion Date
May 1, 2029
Completion Date
May 15, 2029
Last Updated
January 21, 2026
80
ESTIMATED participants
Acalabrutinib
DRUG
Venetoclax
DRUG
AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479information.center@astrazeneca.comLead Sponsor
AstraZeneca
Collaborators
NCT06043011
NCT06528301
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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