About this trial
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 criteria
Qualifiers
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.
IGHV (mutated vs. unmutated)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Acalabrutinib
- Venetoclax