A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05624554

Patient View

This study evaluates nemtabrutinib against standard chemoimmunotherapy in untreated CLL/SLL patients without TP53 aberrations. Eligible participants must have active disease and be able to swallow oral medication. Interventions include nemtabrutinib, fludarabine, cyclophosphamide, bendamustine, and various rituximab biosimilars, administered in specified cycles.

Patient Parameters

Program Overview

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).

Eligibility Criteria

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

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