Study

Overview

Official Title: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations

The purpose of this study is to evaluate the efficacy and safety of nemtabrutinib compared to investigator’s choice of fludarabine plus cyclophosphamide plus rituximab (FCR) or bendamustine plus rituximab (BR) in participants with previously untreated CLL/SLL without 17p deletion and/or tumor protein (TP) 53 mutation. The primary hypothesis is that nemtabrutinib is superior to FCR/BR with respect to progression-free survival (PFS).

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

300

Study Start Date:

March 2023

Estimated Study Completion Date:

March 2031

Estimated Primary Completion Date:

May 2027

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status
The ability to swallow and retain oral medication

Exclusion Criteria:

Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
History of severe bleeding disorders
Not adequately recovered from major surgery or has ongoing surgical complications

Locations

United States Toll Free Number 1-800-770-4674

Springdale, Arkansas, 72762
Clermont, Florida, 34711
Hattiesburg, Mississippi, 39401
Spokane, Washington, 99208

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-1026-008

Study Detail

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)