Tests nemtabrutinib against standard drugs in untreated chronic lymphocytic leukemia
Compares nemtabrutinib with ibrutinib or acalabrutinib in adults with untreated leukemia.
Plain-language title generated from the registry record
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)
Key facts
- Where
- Ankara, Antalya, Edirne, Istanbul, Izmir, and Samsun, TürkiyeSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 12 November 2026.
Where in Türkiye
- Ankara Bilkent Şehir Hastanesi-Medical Oncology (Site 1407)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Ankara Universitesi Tip Fakultesi Hastanesi-hematology (Site 1401)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Antalya Egitim ve Arastırma Hastanesi (Site 1409)Antalya, TürkiyeContact: Study CoordinatorTaking people
- Trakya University Medical Faculty Hospital-Hematology (Site 1403)Edirne, TürkiyeContact: Study CoordinatorTaking people
- Mega Medipol (Site 1412)Istanbul, TürkiyeContact: Study CoordinatorTaking people
- Sisli Florence Nightingale Hastanesi (Site 1411)Istanbul, TürkiyeContact: Study CoordinatorTaking people
- Marmara Universitesi Pendik Egitim Arastirma Hastanesi (Site 1408)Istanbul, TürkiyeContact: Toll Free NumberNo longer taking part
- Ege Universitesi Hastanesi (Site 1404)Izmir, TürkiyeContact: Study CoordinatorTaking people
- Ondokuz Mays Üniversitesi (Site 1410)Samsun, TürkiyeContact: Study CoordinatorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06136559EU 2022-501697-19-01
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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.