Spots Global Cancer Trial Database for A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010)
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Trial Identification
Brief Title: A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010)
Official Title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)
Study ID: NCT05947851
Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group ( Site 5405), Springdale, Arkansas, United States
MemorialCare Health System - Long Beach Medical Center ( Site 5421), Long Beach, California, United States
Memorial Hospital West ( Site 5410), Pembroke Pines, Florida, United States
Medical Oncology Associates, PS ( Site 5406), Spokane, Washington, United States
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423), Madison, Wisconsin, United States
Instituto Alexander Fleming ( Site 1005), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007), Mar del Plata, Buenos Aires, Argentina
Hospital Aleman-oncohematologic diseases ( Site 1001), Buenos Aires, Caba, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002), Buenos Aires, Caba, Argentina
Sanatorio Parque ( Site 1003), Rosario, Santa Fe, Argentina
Centro Medico Fleischer ( Site 1006), Buenos Aires, , Argentina
Royal Adelaide Hospital ( Site 1104), Adelaide, South Australia, Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103), Melbourne, Victoria, Australia
UZ Leuven-Hematology ( Site 1200), Leuven, Vlaams-Brabant, Belgium
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308), São Paulo, Sao Paulo, Brazil
The Moncton Hospital ( Site 1414), Moncton, New Brunswick, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer, Sherbrooke, Quebec, Canada
Biocenter ( Site 1507), Concepción, Biobio, Chile
IC La Serena Research ( Site 1506), La Serena, Coquimbo, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509), Santiago, Region M. De Santiago, Chile
FALP-UIDO ( Site 1500), Santiago, Region M. De Santiago, Chile
Clínica Inmunocel ( Site 1511), Santiago, Region M. De Santiago, Chile
Fundación Valle del Lili ( Site 1703), Cali, Valle Del Cauca, Colombia
Hopital Claude Huriez - CHU de Lille ( Site 2107), Lille, Nord, France
Centre Hospitalier Universitaire Estaing ( Site 2105), Clermont-Ferrand, Puy-de-Dome, France
CHD Vendee ( Site 2100), La Roche-sur-Yon, Vendee, France
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203), Trier, Rheinland-Pfalz, Germany
Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201), Leipzig, Sachsen, Germany
Rambam Health Care Campus ( Site 2801), Haifa, , Israel
Hadassah Medical Center-Hemato-Oncology ( Site 2812), Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 2809), Ramat Gan, , Israel
Sourasky Medical Center ( Site 2811), Tel Aviv, , Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant, Alessandria, , Italy
Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902), Milano, , Italy
Arcispedale Santa Maria Nuova-Hematology ( Site 2900), Reggio Emilia, , Italy
Auxilio Mutuo Cancer Center ( Site 3900), San Juan, , Puerto Rico
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401), Moreletta Park, Gauteng, South Africa
Groote Schuur Hospital ( Site 4400), Cape Town, Western Cape, South Africa
Haemalife ( Site 4407), Kuilsriver, Western Cape, South Africa
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601), L'Hospitalet Del Llobregat, Barcelona, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602), Pozuelo de Alarcon, Madrid, Spain
HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603), Valencia, Valenciana, Comunitat, Spain
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002), Nottingham, England, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 5001), London-Camden, London, City Of, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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