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IC La Serena Research | La Serena, Chile

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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

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

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

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

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

Trial contacts and locations

92

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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