A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Trial Details

NCT ID
NCT05947851
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Nemtabrutinib
  • Venetoclax
  • Rituximab
Locations (sample)
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Long Beach, California, United States|33.76696,-118.18923
  • Pembroke Pines, Florida, United States|26.00315,-80.22394
  • Fort Wayne, Indiana, United States|41.1306,-85.12886
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy
  • Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required b…
  • Relapsed or refractory to at least 1 prior available therapy
  • Have at least 1 marker of disease burden

For full eligibility, visit ClinicalTrials.gov.

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