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NCT05947851 · ClinicalTrials.gov registry record · Phase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
A Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell and CLL, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 735
- Enrollment target
- 20
- Study locations
NCT05947851: Recruiting Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell and CLL, sponsored by Merck Sharp & Dohme.
NCT05947851 is a Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell and CLL that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 735 participants, above the 424-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05947851, a Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell and CLL, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 735 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).
Primary Outcome
DLT evaluation period is defined as 8 weeks after the first dose of the combination treatment of nemtabrutinib plus venetoclax Cycle 2 Day 1 in Part 1 + 4 weeks follow up. Each cycle is 4 weeks. DLTs are: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting \>7 days (except Grade 3 lymphocytosis, Gr
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Nemtabrutinib
- BIOLOGICAL Rituximab
Study Locations (20)
Other
- Centro Medico Fleischer ( Site 1006) - Buenos Aires
- Hospital Aleman-oncohematologic diseases ( Site 1001) - Buenos Aires
- ZAS Cadix ( Site 1203) - Antwerp
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) - São Paulo
Buenos Aires
- Instituto Alexander Fleming ( Site 1005) - Ciudad Autónoma de Buenos Aires
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007) - Mar del Plata
Region M. de Santiago
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) - Santiago
- FALP-UIDO ( Site 1500) - Santiago
Arkansas
- Highlands Oncology Group ( Site 5405) - Springdale
California
- MemorialCare Health System - Long Beach Medical Center ( Site 5421) - Long Beach
Florida
- Memorial Hospital West ( Site 5410) - Pembroke Pines
Oregon
- Oregon Health and Science University ( Site 5425) - Portland
Washington
- Medical Oncology Associates, PS ( Site 5406) - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 735 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2035-07-01 |
| Phase | Phase 3 |
What NCT05947851 shows while recruiting
NCT05947851 is an interventional study that assigns participants to a tested intervention. The registered 735 participants enrollment target is mid-sized for trials with a published cap, above the 424-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (73% higher).
The record links to 6 conditions, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05947851 names 20 study sites across 15 states, led by Other, Buenos Aires, Region M. de Santiago.
Frequently Asked Questions
What is clinical trial NCT05947851 about?
NCT05947851 is a clinical study titled "A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).". The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progre...
What is the current status of trial NCT05947851?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 735 participants. The study started on 2023-08-08. Estimated completion is 2035-07-01.
What conditions does trial NCT05947851 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell, CLL, SLL, Lymphoma, Small Lymphocytic, Leukemia, Chronic Lymphocytic.
What interventions are being tested in trial NCT05947851?
The interventions under investigation include: Venetoclax (DRUG), Nemtabrutinib (DRUG), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05947851?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05947851 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Oregon, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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