Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Jennifer Woyach
- Study ID
- NCT07557056
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Bone Marrow Aspiration — PROCEDUREUndergo bone marrow aspiration and biopsy
- Bone Marrow Biopsy — PROCEDUREUndergo bone marrow aspiration and biopsy
- Computed Tomography — PROCEDUREUndergo CT
- Nemtabrutinib — DRUGGiven PO
- Questionnaire Administration — OTHERAncillary studies
- Venetoclax — DRUGGiven PO
Study Details
This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (nemtabrutinib and venetoclax)Patients receive nemtabrutinib PO daily on days 1-28 of each cycle. Starting in cycle 3, patients also receive venetoclax PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, bone marrow aspiration and biopsy, and blood sample collection throughout the trial.
Primary Outcome Measure
Presence of undetectable minimal residual disease (MRD) [ Time Frame: After 14 cycles of treatment (cycle length = 28 days) ]
Central Contacts
- The Ohio State University Comprehensive Cancer Center800-293-5066
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Jennifer A. Woyach, MD (PRINCIPAL_INVESTIGATOR) |
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