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)
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT05624554
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nemtabrutinib Nemtabrutinib Administered daily via oral tablet. FCR or BR Ruxience 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. FCR or BR Rituximab 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. FCR or BR Truxima 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. FCR or BR Cyclophosphamide 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. FCR or BR Fludarabine 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. FCR or BR Bendamustine 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. FCR or BR Riabni 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 49 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR).
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR Up to approximately 94 months For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL criteria as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR Up to approximately 36 months ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or Partial response (PR), per iwCLL criteria 2018 as assessed by BICR.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 94 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Overall Survival (OS) Up to approximately 94 months OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experience an Adverse Event (AE) Up to approximately 94 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Trial Locations
- Locations (97)
Highlands Oncology Group ( Site 5205)
🇺🇸Springdale, Arkansas, United States
Clermont Oncology Center ( Site 5224)
🇺🇸Clermont, Florida, United States
Hattiesburg Clinic Hematology/Oncology ( Site 5216)
🇺🇸Hattiesburg, Mississippi, United States
Medical Oncology Associates, PS ( Site 5206)
🇺🇸Spokane, Washington, United States
Royal Adelaide Hospital ( Site 1105)
🇦🇺Adelaide, South Australia, Australia
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)
🇧🇷Curitiba, Parana, Brazil
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
🇧🇷Jaú, Sao Paulo, Brazil
A. C. Camargo Cancer Center ( Site 1318)
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319)
🇧🇷Rio de Janeiro, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
🇧🇷Sao Paulo, Brazil
Scroll for more (87 remaining)Highlands Oncology Group ( Site 5205)🇺🇸Springdale, Arkansas, United States