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NCT05624554 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05624554: Active Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Merck Sharp & Dohme.
NCT05624554 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 300 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05624554, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Nemtabrutinib
- BIOLOGICAL Rituximab
- DRUG Bendamustine
Study Locations (20)
Other
- Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319) - Rio de Janeiro
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) - São Paulo
- Hospital Paulistano-Americas Oncologia ( Site 1302) - São Paulo
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404) - Plovdiv
- Medical Centre Pratia Clinic EOOD ( Site 6406) - Plovdiv
- UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400) - Stara Zagora
- Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402) - Vratsa
Region M. de Santiago
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) - Santiago
- FALP-UIDO ( Site 1500) - Santiago
- Clínica Inmunocel ( Site 1511) - Santiago
São Paulo
- Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304) - Jaú
- A. C. Camargo Cancer Center ( Site 1318) - São Paulo
Arkansas
- Highlands Oncology Group ( Site 5205) - Springdale
Florida
- Clermont Oncology Center ( Site 5224) - Clermont
Mississippi
- Hattiesburg Clinic Hematology/Oncology ( Site 5216) - Hattiesburg
Washington
- Medical Oncology Associates, PS ( Site 5206) - Spokane
South Australia
- Royal Adelaide Hospital ( Site 1105) - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2031-03-17 |
| Phase | Phase 3 |
What the registry record for NCT05624554 still lists
NCT05624554 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% higher).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05624554 names 20 study sites across 11 states, led by Other, Region M. de Santiago, São Paulo.
Frequently Asked Questions
What is clinical trial NCT05624554 about?
NCT05624554 is a clinical study titled "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)". 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 liv...
What is the current status of trial NCT05624554?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-03-16. Estimated completion is 2031-03-17.
What conditions does trial NCT05624554 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT05624554?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Nemtabrutinib (DRUG), Rituximab (BIOLOGICAL), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT05624554?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624554 being conducted?
This trial has 20 study locations across Arkansas, Florida, Mississippi, Washington, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05624554's enrollment target sits among peer trials
300 29th of 187 higher than 158 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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