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)
Running, not enrolling · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
In brief
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).
Key facts
- Study ID
- NCT05624554
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 300
- Starts
- 2023-03-16
- Expected to finish
- 2031-03-17
- Last updated by the study team
- 2026-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Has gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
- Has 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
- Has history of severe bleeding disorders
- Has not adequately recovered from major surgery or has ongoing surgical complications
Where it is running
- 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, Paraná, Brazil
- Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304) — Jaú, São Paulo, Brazil
- A. C. Camargo Cancer Center ( Site 1318) — São Paulo, São 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) — São Paulo, Brazil
- Hospital Paulistano-Americas Oncologia ( Site 1302) — São Paulo, Brazil
- Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403) — Sofia, Sofia (stolitsa), Bulgaria
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404) — Plovdiv, Bulgaria
- Medical Centre Pratia Clinic EOOD ( Site 6406) — Plovdiv, Bulgaria
- UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400) — Stara Zagora, Bulgaria
- Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402) — Vratsa, Bulgaria
- James Lind Centro de Investigacion del Cancer ( Site 1503) — Temuco, Araucania, Chile
- Biocenter ( Site 1507) — Concepción, Biobio, Chile
- IC La Serena Research ( Site 1506) — La Serena, Coquimbo Region, Chile
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) — Santiago, Region M. de Santiago, Chile
- FALP-UIDO ( Site 1500) — Santiago, Region M. de Santiago, Chile
- Clínica Inmunocel ( Site 1511) — Santiago, Region M. de Santiago, Chile
- Peking University Third Hospital ( Site 1602) — Beijing, Beijing Municipality, China
- Chongqing University Cancer Hospital ( Site 1605) — Chongqing, Chongqing Municipality, China
- Chongqing University Three Gorges Hospital ( Site 1609) — Chongqing, Chongqing Municipality, China
- Highlands Oncology Group ( Site 5205) — Springdale, Arkansas, United States
Full record on ClinicalTrials.gov
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