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A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations


Description

Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).

Trial Eligibility

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy * Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status * The ability to swallow and retain oral medication Exclusion Criteria: * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) * Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy * History of severe bleeding disorders * Not adequately recovered from major surgery or has ongoing surgical complications

Study Info

Organization

Merck Sharp & Dohme LLC


Primary Outcome

Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)


Outcome Timeframe Up to approximately 49 months

NCTID NCT05624554

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2023-03-16

Completion Date 2027-05-19

Enrollment Target 300

Interventions

DRUG Nemtabrutinib

DRUG Fludarabine

DRUG Cyclophosphamide

DRUG Bendamustine

BIOLOGICAL Rituximab

BIOLOGICAL Truxima

BIOLOGICAL Ruxience

BIOLOGICAL Riabni

Locations Recruiting

Highlands Oncology Group ( Site 5205)

United States, Arkansas, Springdale


Clermont Oncology Center ( Site 5224)

United States, Florida, Clermont


Hattiesburg Clinic Hematology/Oncology ( Site 5216)

United States, Mississippi, Hattiesburg


Medical Oncology Associates, PS ( Site 5206)

United States, Washington, Spokane


Royal Adelaide Hospital ( Site 1105)

Australia, South Australia, Adelaide


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