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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Nemtabrutinib — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Venetoclax — DRUG
    Given 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

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Jennifer A. Woyach, MD
614-293-3196
Jennifer A. Woyach, MD (PRINCIPAL_INVESTIGATOR)

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