Nemtabrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jennifer Woyach

Must not be taking: CYP3A inducers, CYP3A inhibitors

Disqualifiers: Other malignancies, Cardiovascular disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 cycles (approximately 12 months)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jennifer A Woyach, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My disease has spread to organs outside the lymph nodes and is causing symptoms.

I have lost 10% or more of my body weight without trying in the past 6 months.

I experience significant fatigue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemtabrutinib daily on days 1-28 of each cycle. Starting in cycle 3, participants also receive venetoclax daily on days 1-28. Cycles repeat every 28 days for up to 14 cycles.

14 cycles (approximately 12 months)

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including CT, bone marrow aspiration and biopsy, and blood sample collection.

Every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nemtabrutinib
• Venetoclax

How Is the Trial Designed?

Group I: Treatment (nemtabrutinib and venetoclax) Experimental Treatment 7 Interventions

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.

Who Is Running the Clinical Trial?

Jennifer Woyach

Lead Sponsor

Trials

4

Recruited

100+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University