MedTrace Logo

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).

NCT05947851 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 735

Last updated 2026-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2032-06-01
Completion
2035-07-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Puerto Rico
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05947851 on ClinicalTrials.gov