Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Po… (NCT07024706) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
United States, Austria, Czechia80 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
✕. Significant cardiovascular or cerebrovascular disease.
✕. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
✕. Child-Pugh B/C liver cirrhosis.
✕. History of prior or current malignancy.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: ORR assessed at multiple timepoints during treatment period (each cycle is 28 days). Timepoint for primary analysis is at completion of cycle 14