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
AstraZeneca
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.
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)…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: 1. Participant must be ≥ 18 years at the time of signing informed consent. 2. Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018) 3. 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. 4. The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: 1. IGHV (mutated vs. unmutated) 2. del(17p) (present or absent…
Interventions
- DrugAcalabrutinib
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.
- DrugVenetoclax
Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2
Locations (29)
- Research SiteBoston, Massachusetts
- Research SiteCharlotte, North Carolina
- Research SiteDurham, North Carolina
- Research SiteHorn
- Research SiteBrno
- Research SiteHradec Kralova