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)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
Phase 3

Conditions

Small Lymphocytic Leukemia
Chronic Lymphocytic Leukemia

Treatments

Biological: Truxima
Drug: Cyclophosphamide
Biological: Riabni
Drug: Fludarabine
Drug: Nemtabrutinib
Biological: Ruxience
Biological: Rituximab
Drug: Bendamustine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05624554
1026-008
MK-1026-008 (Other Identifier)
2021-006593-23 (EudraCT Number)
2022-500164-35-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Nemtabrutinib
Experimental group
Description:
Administered daily via oral tablet.
Treatment:
Drug: Nemtabrutinib
FCR or BR
Active Comparator group
Description:
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
Treatment:
Biological: Rituximab
Drug: Bendamustine
Biological: Ruxience
Drug: Fludarabine
Biological: Riabni
Drug: Cyclophosphamide
Biological: Truxima

Trial contacts and locations

89

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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