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NCT06136559 · ClinicalTrials.gov registry record · Phase 3
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT06136559 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, above the 175-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (586% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT06136559, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Conditions Studied
Interventions
- DRUG Nemtabrutinib
- DRUG Acalabrutinib
- DRUG Ibrutinib
Study Locations (20)
Arizona
- Banner MD Anderson Cancer Center ( Site 0059) - Gilbert
- Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051) - Phoenix
- Arizona Oncology Associates - NAHOA ( Site 8007) - Prescott
Colorado
- Saint Joseph Hospital ( Site 0026) - Denver
- Lutheran Medical Center ( Site 0027) - Golden
- Intermountain Health St. Mary's Regional Hospital ( Site 0025) - Grand Junction
Florida
- Clermont Oncology Center ( Site 0046) - Clermont
- Florida Cancer Specialists - South ( Site 7001) - Fort Myers
- Florida Cancer Specialists - East ( Site 7002) - West Palm Beach
California
- Alta Bates Summit Medical Center ( Site 0004) - Berkeley
- Moores Cancer Center ( Site 0003) - La Jolla
Iowa
- University of Iowa Health Care. ( Site 0017) - Waukee
- University of Iowa Health Care. ( Site 0057) - Waukee
Alabama
- USA Mitchell Cancer Institute ( Site 0014) - Mobile
Connecticut
- Eastern CT Hematology & Oncology Associates ( Site 0033) - Norwich
Indiana
- Parkview Research Center at Parkview Regional Medical Center ( Site 0002) - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2032-09-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06136559
The ClinicalTrials.gov registry entry for NCT06136559 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (586% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Nemtabrutinib is the first listed.
NCT06136559 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Arizona, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06136559 about?
NCT06136559 is a clinical study titled "A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)". The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is...
What is the current status of trial NCT06136559?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2023-12-13. Estimated completion is 2032-09-07.
What conditions does trial NCT06136559 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT06136559?
The interventions under investigation include: Nemtabrutinib (DRUG), Acalabrutinib (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT06136559?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06136559 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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