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)

Status and phase: Active, not recruiting; Phase 3

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624554

1026-008

MK-1026-008 (Other Identifier)

2022-501481-21-00 (Registry Identifier)

2021-006593-23 (EudraCT Number)

Details and patient eligibility

About

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).

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

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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:

Drug: Fludarabine

Biological: Rituximab

Biological: Ruxience

Biological: Truxima

Biological: Riabni

Drug: Bendamustine

Drug: Cyclophosphamide