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Recruiting Phase 3 NCT06136559

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)

Phase 3 – large-scale trial before approval
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: 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 Criteria: The main exclusion criteria include but are not limited to the following: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection. * Has gastrointestinal (GI) dysfunction that may affect drug absorption. * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL. * Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening. * 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 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. * Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Locations 27
Australia (1)
Royal North Shore Hospital ( Site 2806)
St Leonards , New South Wales
COMPLETED
Belgium (1)
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen , Antwerpen
Study Coordinator
Brazil (1)
Hospital 9 De Julho ( Site 2206)
São Paulo , São Paulo
Study Coordinator
Canada (1)
BC Cancer Kelowna ( Site 0112)
Kelowna , British Columbia
Study Coordinator
Chile (1)
FALP-UIDO ( Site 2300)
Santiago , Region M. de Santiago
Study Coordinator
China (1)
Anhui Provincial Cancer Hospital ( Site 2001)
Hefei , Anhui
Study Coordinator
Colombia (1)
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Valledupar , Cesar Department
Study Coordinator
Czech Republic (1)
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové
Study Coordinator
Denmark (1)
Aalborg Universitetshospital, Syd ( Site 0403)
Aalborg , North Denmark
Study Coordinator
Greece (1)
Evangelismos General Hospital of Athens ( Site 0700)
Athens , Attica
Study Coordinator
Hong Kong (1)
Queen Mary Hospital ( Site 3300)
Hong Kong
Study Coordinator
Israel (1)
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa
Study Coordinator
Japan (1)
Nagoya University Hospital ( Site 1907)
Nagoya , Aichi-ken
ACTIVE_NOT_RECRUITING
Malaysia (1)
University Malaya Medical Centre ( Site 1604)
Lembah Pantai , Kuala Lumpur
Study Coordinator
Mexico (1)
Centro de Infusion Superare ( Site 2602)
Mexico City , Mexico City
Study Coordinator
New Zealand (1)
Waikato Hospital-Haematology ( Site 3202)
Hamilton , Waikato Region
Study Coordinator
Norway (1)
Akershus Universitetssykehus ( Site 0902)
Lørenskog , Akershus
Study Coordinator
Peru (1)
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Arequipa , Ariqipa
Study Coordinator
Poland (1)
Pratia MCM Krakow ( Site 1007)
Krakow , Lesser Poland Voivodeship
Study Coordinator
South Africa (1)
Wits Clinical Research ( Site 1102)
Johannesburg , Gauteng
Study Coordinator
Spain (1)
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
L'Hospitalet Del Llobregat , Barcelona
Study Coordinator
Sweden (1)
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm , Stockholm County
Study Coordinator
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
Kaohsiung City
Study Coordinator
Thailand (1)
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Bangkok , Bangkok
Study Coordinator
Turkey (1)
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Ankara
Study Coordinator
United Kingdom (1)
Southmead Hospital ( Site 3010)
Bristol , Bristol, City of
COMPLETED
United States (1)
USA Mitchell Cancer Institute ( Site 0014)
Mobile , Alabama
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.12.2023
Completion date
07.09.2032
Registry ID
NCT06136559
Source
anzctr
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