NCT05947851

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).

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Chronic Lymphocytic
• Small-Cell Lymphoma
• Lymphoma, Small Lymphocytic
• CLL
• SLL

Interventions

Type	Name	Description
DRUG	Nemtabrutinib	5, 20, 45, and 65 mg tablets
DRUG	Venetoclax	10, 50, and 100 mg tablets
BIOLOGICAL	Rituximab	100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

Timeline

• Start date: 2023-08-08
• Primary completion: 2032-06-01
• Completion: 2035-07-01
• First posted: 2023-07-17
• Last updated: 2026-03-13

Locations

52 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Israel, Italy, Mexico, Puerto Rico, South Africa, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study