Език: EN EN
← Назад към резултатите
Набира участници Фаза 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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 27
Австралия (1)
Royal North Shore Hospital ( Site 2806)
St Leonards , New South Wales
COMPLETED
Белгия (1)
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen , Antwerpen
Study Coordinator
Бразилия (1)
Hospital 9 De Julho ( Site 2206)
São Paulo , São Paulo
Study Coordinator
Канада (1)
BC Cancer Kelowna ( Site 0112)
Kelowna , British Columbia
Study Coordinator
Chile (1)
FALP-UIDO ( Site 2300)
Santiago , Region M. de Santiago
Study Coordinator
Китай (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
Чехия (1)
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové
Study Coordinator
Дания (1)
Aalborg Universitetshospital, Syd ( Site 0403)
Aalborg , North Denmark
Study Coordinator
Гърция (1)
Evangelismos General Hospital of Athens ( Site 0700)
Athens , Attica
Study Coordinator
Hong Kong (1)
Queen Mary Hospital ( Site 3300)
Hong Kong
Study Coordinator
Израел (1)
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa
Study Coordinator
Япония (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
Норвегия (1)
Akershus Universitetssykehus ( Site 0902)
Lørenskog , Akershus
Study Coordinator
Peru (1)
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Arequipa , Ariqipa
Study Coordinator
Полша (1)
Pratia MCM Krakow ( Site 1007)
Krakow , Lesser Poland Voivodeship
Study Coordinator
South Africa (1)
Wits Clinical Research ( Site 1102)
Johannesburg , Gauteng
Study Coordinator
Испания (1)
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
L'Hospitalet Del Llobregat , Barcelona
Study Coordinator
Швеция (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
Тайланд (1)
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Bangkok , Bangkok
Study Coordinator
Турция (1)
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Ankara
Study Coordinator
Великобритания (1)
Southmead Hospital ( Site 3010)
Bristol , Bristol, City of
COMPLETED
САЩ (1)
USA Mitchell Cancer Institute ( Site 0014)
Mobile , Alabama
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.12.2023
Крайна дата
07.09.2032
Регистрационен номер
NCT06136559
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.