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Taking people in DenmarkPhase 3

Tests nemtabrutinib against standard drugs in untreated chronic lymphocytic leukemia

Compares nemtabrutinib with ibrutinib or acalabrutinib in adults with untreated leukemia.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Aalborg, Odense C, and Roskilde, DenmarkSee the 3 sitesAlso in 28 other countries, 202 sites
Trial code
Registry title
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)
Status
Recruiting
Phase
Phase 3
People taking part
1,200 people, planned
Started
13 Dec 2023
Expected to end
7 Sept 2032
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Nemtabrutinib
  • Ibrutinib
  • Acalabrutinib
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have never had treatment for it and whose disease needs treatment now.

Age
18 years or older
Sex
All sexes can join
Disease stage
Confirmed CLL/SLL with active disease that clearly needs treatment to start, and at least 1 marker of disease burden. ECOG performance status 0 to 2 within 7 days before randomization.
Earlier treatment
Cannot have had any systemic anticancer therapy for CLL/SLL before.

Main reasons for not taking part

  • Active hepatitis B or hepatitis C infection
  • Richter Transformation or active central nervous system involvement by CLL/SLL
  • Clinically significant cardiovascular disease or a history of severe bleeding disorder
  • Another cancer that is getting worse or needed active treatment in the past 2 years
  • Stomach or bowel problems that may affect how the drug is absorbed

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • The main inclusion criteria include but are not limited to the following:
  • Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy
  • Has at least 1 marker of disease burden
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization
  • Has the ability to swallow and retain oral medication
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening
  • Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria

Who cannot take part

  • Has gastrointestinal (GI) dysfunction that may affect drug absorption
  • Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening
  • Has received any systemic anticancer therapy for CLL/SLL
  • Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
  • Has clinically significant cardiovascular disease
  • Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients
  • Has history of severe bleeding disorder
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening
  • The main exclusion criteria include but are not limited to the following:
  • Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL

Where in Denmark

Also in 28 other countries, 202 sites

  • Aalborg University HospitalAalborg, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people
  • Region SjaellandRoskilde, DenmarkTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • NemtabrutinibTreatment being tested

    Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.

  • Ibrutinib/AcalabrutinibExisting treatment, for comparison

    Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.

    Treatment: Ibrutinib and Acalabrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
Plain-language title
Tests nemtabrutinib against standard drugs in untreated chronic lymphocytic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 October 2026