Study of Acalabrutinib and Venetoclax for Relapsed CLL/SLL
This study is looking at a combination of two oral medications, acalabrutinib and venetoclax, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back after previous treatment. You may be able to join if you've already received a specific first-line treatment (covalent BTKi plus BCL2i therapy, possibly with obinutuzumab) and responded well for at least two years. The study aims to see how many people respond to this new combination treatment. Researchers will also look at a biomarker called TP53 to help understand disease risk. The study plans to enroll 80 participants, but its current status is unclear.
- Study design
- This is an interventional study that plans to enroll 80 participants. Participants will be grouped into low or high-risk cohorts based on specific genetic markers.
- What's involved
- The study duration for each participant will be up to 5 years, including screening, treatment, and post-intervention follow-up periods.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study duration for each participant will be up to 5 years, which includes a post-intervention follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
At a glance
Conditions
Where it's being run
36 sites across 9 statesWho to contact
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What this trial measures
- Overall Response Rate (ORR)ORR assessed at multiple timepoints during treatment period (each cycle is 28 days). Timepoint for primary analysis is at completion of cycle 14
ORR, defined as the proportion of participants who achieve best response of CR, CRi, nPR, or PR per iwCLL criteria as assessed by the investigator.