Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Merck Sharp & Dohme.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist → Add completion date to calendar (.ics) →

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.

Primary Outcome

ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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
Merck Sharp & Dohme

558 total trials

What NCT06136559 shows while recruiting

NCT06136559 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 175-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (586% higher).

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 names 20 study sites across 12 states, led by 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.

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 NCT06136559's enrollment target sits among peer trials

1,200 5th of 187 higher than 183 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00001987 · 1,200 participants

    Genetic Studies of Insulin and Diabetes

  • NCT00477100 · 1,200 participants

    Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer

  • NCT01209000 · 1,200 participants

    Nephrotic Syndrome Study Network

  • NCT01944332 · 1,200 participants · NA

    Gamete Treatment to Correct Fertilization Failure

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06136559

Source: ClinicalTrials.gov NCT06136559, the US trial registry maintained by the National Library of Medicine. NCT06136559 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.