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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 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.

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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).

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

FieldValue
Enrollment Target 735 participants
Start Date 2023-08-08
Est. Completion 2035-07-01
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT05947851

The ClinicalTrials.gov registry entry for NCT05947851 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 735 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 424-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (73% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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