Nemtabrutinib Plus Venetoclax vs Venetoclax Plus Rituximab in Relapsed/Refractory CLL/SLL
13 Mar 20265 min read0 viewsINTERVENTIONAL Trial
GIST (Key Takeaways)
Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010) Summary: 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).
A Phase 3, open-label, randomized trial compares nemtabrutinib (MK-1026) plus venetoclax versus venetoclax plus rituximab in relapsed/refractory CLL/SLL following at least one prior therapy.
Primary aim is to evaluate progression-free survival (PFS) by 2018 iwCLL criteria, assessed via blinded independent central review (BICR).
Population and Intervention
Population: participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least one prior treatment.
Interventions: nemtabrutinib plus venetoclax versus venetoclax plus rituximab.
Context and Outcomes
The study seeks to assess safety and tolerability and to confirm the appropriate dose for the nemtabrutinib–venetoclax combination.
Primary hypothesis is that nemtabrutinib with venetoclax improves PFS compared with VR (venetoclax plus rituximab) per iwCLL criteria.
Status and Scope
Enrollment is estimated at 735 participants.
Status is Recruiting, with an anticipated completion date around July 1, 2035.
Limitations
Source does not provide numerical results, specific safety signals, or detailed secondary endpoints.
Source Reference
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