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RECRUITING 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)

NCT06136559 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,200 participants
Start Date 2023-12-13
Est. Completion 2032-09-07
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06136559 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Arizona, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06136559?

The interventions under investigation include: Nemtabrutinib (DRUG), Acalabrutinib (DRUG), Ibrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06136559?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial