Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Start Date
6/4/2026
Completion Date
3/23/2033
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Acalabrutinib
Venetoclax
Conditions
Locations
Research Site
Boston, Massachusetts 02215
United States
Research Site
Charlotte, North Carolina 28204
United States
Research Site
Charlotte, North Carolina 28204
United States
Research Site
Durham, North Carolina 27705
United States
Research Site
Winston-Salem, North Carolina 27103
United States
Research Site
Horn, 3580
Austria
Research Site
Goiânia, 74605-020
Brazil
Research Site
Porto Alegre, 90035-903
Brazil
Research Site
Porto Alegre, 90110-270
Brazil
Research Site
São Paulo, 01246-000
Brazil
Research Site
São Paulo, 1409
Brazil
Research Site
Brno, 625 00
Czechia
Research Site
Hradec Kralova, 50005
Czechia
Research Site
Ostrava, 708 502
Czechia
Research Site
Dublin, 7
Ireland
Research Site
Dublin, D08 NHY1
Ireland
Research Site
Meldola, 47014
Italy
Research Site
Milan, 20132
Italy
Research Site
Milan, 20162
Italy
Research Site
Padua, 35128
Italy
Research Site
Ravenna, 48121
Italy
Research Site
Rome, 00168
Italy
Research Site
Torino, 10126
Italy
Research Site
Bydgoszcz, 85-168
Poland
Research Site
Krakow, 30-727
Poland
Research Site
Lodz, 93-513
Poland
Research Site
Lublin, 20-090
Poland
Research Site
Warsaw, 02-172
Poland
Research Site
Warsaw, 02-776
Poland
Research Site
Barcelona, 08041
Spain
Research Site
Barcelona, 8035
Spain
Research Site
Granada, 18014
Spain
Research Site
Madrid, 28031
Spain
Research Site
Madrid, 28034
Spain
Research Site
Madrid, 28041
Spain
Research Site
Majadahonda, 28222
Spain