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)

Phase 3 Active not recruiting 300 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

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).

Timeline

Start: 2023-03-16
Primary completion: 2027-05-19
Completion: 2031-03-17

Publications

Davids MS. BRUIN 313 and 314 Trials Open the Door for Noncovalent Bruton Tyrosine Kinase Inhibition as Initial Therapy for Chronic Lymphocytic Leukemia. J Clin Oncol. 2026 Feb 20;44(6):435-439. doi: 10.1200/JCO-25-02691. Epub 2025 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bendamustine	Small molecule	90 mg/m2	Intravenous
Comparator	Cyclophosphamide	Other / unclassified	250 mg/m2	Intravenous
Comparator	Fludarabine	Small molecule	25 mg/m2	Intravenous
Subject	Nemtabrutinib	Other / unclassified	65 mg	Oral
Comparator	Riabni	Unknown	500 mg/m2	Intravenous
Comparator	Rituximab	Monoclonal antibody	500 mg/m2	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications