Find Chronic Lymphocytic Leukemia (CLL) Clinical Trials Near You
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
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• Participant must be ≥ 18 years at the time of signing informed consent.
• Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018)
• Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment.
• The following data must be available or at least the appropriate samples drawn/acquired prior to dosing:
‣ IGHV (mutated vs. unmutated)
⁃ del(17p) (present or absent)
⁃ TP53 mutation (present or absent)
• ECOG performance status 0, 1 or 2
• Adequate organ and bone marrow (BM) function.
Locations
United States
Massachusetts
Research Site
RECRUITING
Boston
North Carolina
Research Site
RECRUITING
Charlotte
Research Site
WITHDRAWN
Charlotte
Research Site
RECRUITING
Durham
Research Site
RECRUITING
Winston-salem
Other Locations
Austria
Research Site
RECRUITING
Horn
Brazil
Research Site
NOT_YET_RECRUITING
Goiânia
Research Site
NOT_YET_RECRUITING
Porto Alegre
Research Site
NOT_YET_RECRUITING
Porto Alegre
Research Site
NOT_YET_RECRUITING
São Paulo
Research Site
NOT_YET_RECRUITING
São Paulo
Ireland
Research Site
RECRUITING
Dublin
Research Site
RECRUITING
Dublin
Italy
Research Site
RECRUITING
Meldola
Research Site
WITHDRAWN
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
RECRUITING
Padua
Research Site
RECRUITING
Ravenna
Research Site
WITHDRAWN
Rome
Research Site
WITHDRAWN
Torino
Poland
Research Site
NOT_YET_RECRUITING
Bydgoszcz
Research Site
WITHDRAWN
Krakow
Research Site
WITHDRAWN
Lodz
Research Site
NOT_YET_RECRUITING
Lublin
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Warsaw
Spain
Research Site
RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
RECRUITING
Granada
Research Site
RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Majadahonda
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2026-06-04
Estimated Completion Date:2033-03-23
Participants
Target number of participants:80
Treatments
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.