Study on Bruton Tyrosine Kinase Inhibitor with or without Venetoclax for Veterans with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor: VA Office of Research and Development
ClinicalTrials ID:NCT06520098
This clinical trial is comparing two treatment options for veterans with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It aims to find out if adding the drug venetoclax to the current treatment with Bruton Tyrosine Kinase Inhibitors (BTKi) can improve outcomes.
Patient Parameters
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Program Overview
The study is designed to compare the effectiveness of continuing treatment with Bruton Tyrosine Kinase Inhibitors (BTKi) alone versus adding another drug, venetoclax, for one year in veterans with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). After one year, the treatment with both drugs will be stopped, and participants will be closely monitored to see if the cancer remains under control without ongoing medication.
Description
This study involves veterans with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are currently being treated with Bruton Tyrosine Kinase Inhibitors (BTKi) such as ibrutinib, acalabrutinib, or zanubrutinib. These medications are taken as pills. Another treatment option for CLL/SLL is a pill called venetoclax.
Typically, patients on BTKi therapy continue taking it indefinitely unless it stops working or causes significant side effects. Recent studies have shown that combining BTKi with venetoclax for one to two years can be very effective, allowing patients to stop treatment.
This study aims to determine if adding venetoclax to the treatment of patients who have been on BTKi for at least six months and are responding well can better control CLL/SLL and allow them to safely stop treatment. The study will also assess the side effects and effectiveness of this combination in veterans, as well as its impact on their quality of life.
Participants who meet the eligibility criteria will be randomly assigned to one of two groups:
- ARM A (BTKI ALONE): About 50 participants will continue with BTKi treatment alone.
- ARM B (BTKI PLUS VENETOCLAX): About 50 participants will receive both BTKi and venetoclax for one year.
Participants will not be charged for treatments or procedures that are part of the study. However, they will still be responsible for any usual co-payments for VA care and medications not included in the study.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Currently receiving treatment with a BTKi (ibrutinib, acalabrutinib, or zanubrutinib) for at least six months.
- Stable dose of BTKi for the past three months.
- Aged 18 years or older.
- ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Detectable or measurable CLL/SLL in blood or imaging during screening.
- Low risk of tumor lysis syndrome, with all lymph nodes less than 5 cm and specific blood counts within limits.
- Adequate blood cell counts and organ function as determined by specific laboratory tests.
- Able to swallow oral medications and not have conditions affecting absorption.
- Able to receive certain medications to prevent complications.
Exclusion Criteria
- Progression of CLL/SLL on BTKi therapy before starting the study.
- Previous treatment with the combination of BTKi and venetoclax.
- History of certain other blood cancers or transformations.
- Active hepatitis B or C infections unless controlled.
- Severe heart conditions or uncontrolled heart rhythm issues.
- Currently on certain medications that could interfere with the study drugs.
- Need for high doses of steroids or active systemic infections requiring IV antibiotics.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | 94121-1563 | San Francisco | California |
| Kansas City VA Medical Center, Kansas City, MO | 64128-2226 | Kansas City | Missouri |
| Durham VA Medical Center, Durham, NC | 27705-3875 | Durham | North Carolina |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | 98108-1532 | Seattle | Washington |
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