A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Phase 2
100
about 5.3 years
18–80
4 sites in CA, MO, NC +1
What this study is about
This trial is testing whether adding venetoclax to a Bruton Tyrosine Kinase Inhibitor (BTKi) pill improves outcomes for people with CLL or SLL. Participants will continue their current BTKi treatment as long as it's working, or they may receive the BTKi plus venetoclax for one year. After that period, both pills would be stopped and participants will be closely monitored.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Ibrutinib, Acalabrutinib, Zanubrutinib
- 2.Take Venetoclax
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
acalabrutinib, ibrutinib, venetoclax, zanubrutinib
oral (Oral Tablet), oral (Oral Capsule), oral
Primary: The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018
Secondary: CLL/SLL patients' experience through patient reported outcome (PRO) QoL, CLL/SLL patients' experience through patient reported outcome (PRO) measures of fatigue (a key secondary objective), Measure financial toxicity (FT) in CLL/SLL patients, Overall response rate (ORR), per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018., Safety and adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE).
Oncology