Actively Recruiting
Benefit of Venetoclax Addition in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Led by VA Office of Research and Development · Updated on 2025-10-14
100
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial involves people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are currently treated with oral medications called Bruton Tyrosine Kinase Inhibitors (BTKi), such as ibrutinib, acalabrutinib, or zanubrutinib. Researchers are studying whether adding another pill called venetoclax to the ongoing BTKi treatment for one year helps control the disease better and allows patients to stop treatment safely. The study also evaluates side effects, quality of life, and how the combination affects Veterans specifically. Participants are randomly assigned to one of two groups: one continues BTKi treatment alone, and the other adds venetoclax to BTKi for 12 cycles and then stops both pills after one year. Both groups are monitored closely after treatment to track responses and side effects. The study treatments are provided at no cost, and about 50 people will be in each group. During the study, participants will have regular assessments including blood tests, imaging, and patient questionnaires to measure disease response, side effects, quality of life, and fatigue levels. Researchers will evaluate the complete response rate using established criteria over 24 to 36 months. Safety and financial impacts will also be tracked. Participation lasts from the start of treatment through follow-up, with ongoing monitoring after therapy stops to understand long-term outcomes.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by 2018 IWCLL criteria
- Currently receiving BTKi therapy (ibrutinib, acalabrutinib, or zanubrutinib) for at least six months
- Stable dose of BTKi for at least the past three months
- Age between 18 and 80 years
- ECOG performance status between 0 and 2
- Detectable or measurable CLL/SLL in blood or imaging at screening
- Low tumor lysis syndrome risk with lymph nodes less than 5 cm and lymphocyte count below 25 x 10^9/L
- Adequate laboratory values including ANC, platelet count, creatinine clearance, bilirubin, AST, and ALT
- Able to swallow oral medications with no significant gastrointestinal absorption issues
- Able to receive xanthine oxidase inhibitor or rasburicase
You will not qualify if you...
- Progression of CLL/SLL on BTKi therapy before starting study treatment
- Prior treatment with combination of BTKi and venetoclax
- History of Richter's transformation or prolymphocytic leukemia
- Active chronic hepatitis B or hepatitis C infection without viral suppression
- Class III or IV heart failure, unstable angina, or uncontrolled arrhythmia
- Receiving active systemic anticoagulation with heparin or warfarin (must discontinue warfarin 10 days before enrollment)
- Chronic use of strong CYP3A4/5 inhibitors or inducers without appropriate discontinuation
- Use of more than 20 mg prednisone or equivalent corticosteroids daily
- Uncontrolled active systemic infection requiring intravenous antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 cycles (approximately 12 months)
Participants receive either BTKi alone or BTKi combined with venetoclax for 12 cycles.
Regular visits to monitor treatment and side effects
Duration - Up to 36 months
Participants are followed after treatment to assess response, side effects, and quality of life.
Periodic visits during follow-up
Trial Site Locations
Total: 4 locations
1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
2
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128-2226
Actively Recruiting
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
4
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
Research Team
S
Suman Kambhampati, MD MBBS
M
Murali K Nittala, MBBS MS MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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