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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)
Interventions
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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