Actively Recruiting
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)
Led by VA Office of Research and Development · Updated on 2025-10-14
100
Participants Needed
4
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.
CONDITIONS
Official 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...
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Currently receiving BTKi therapy (ibrutinib, acalabrutinib, or zanubrutinib) for at least six months
- Stable BTKi dose 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 during screening
- Low tumor lysis syndrome risk with lymph nodes less than 5 cm and lymphocyte count below 25 x 10^9/L
- Adequate blood counts and kidney and liver function as defined by study criteria
- Able to swallow oral medications with no significant gastrointestinal absorption issues
- Able to receive xanthine oxidase inhibitor or rasburicase if needed
You will not qualify if you...
- Progression of CLL/SLL on BTKi therapy before starting the study
- Prior treatment with combination of BTKi and venetoclax
- History of Richter's transformation or prolymphocytic leukemia
- Active or untreated chronic hepatitis B or C infection
- Class III or IV heart failure, unstable angina, or uncontrolled arrhythmia
- Receiving active systemic anticoagulation with heparin or warfarin
- Use of strong CYP3A4/5 inhibitors or inducers without proper discontinuation
- Requirement of more than 20 mg prednisone or equivalent corticosteroid daily
- Uncontrolled active systemic infection needing intravenous antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Murali K Nittala, MBBS MS MD
CONTACT
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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