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).
Start Date
8/8/2023
Completion Date
7/1/2035
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Nemtabrutinib
Venetoclax
Rituximab
Conditions
Locations
Highlands Oncology Group ( Site 5405)
Springdale, Arkansas 72762
United States
MemorialCare Health System - Long Beach Medical Center ( Site 5421)
Long Beach, California 90806
United States
Memorial Hospital West ( Site 5410)
Pembroke Pines, Florida 33028
United States
Oregon Health and Science University ( Site 5425)
Portland, Oregon 97239-3011
United States
Medical Oncology Associates, PS ( Site 5406)
Spokane, Washington 99208
United States
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
Madison, Wisconsin 53792
United States
Instituto Alexander Fleming ( Site 1005)
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002)
Buenos Aires, Buenos Aires F.D. C1431FWO
Argentina
Sanatorio Parque ( Site 1003)
Rosario, Santa Fe Province S2000DSV
Argentina
Centro Medico Fleischer ( Site 1006)
Buenos Aires, 1414
Argentina
Hospital Aleman-oncohematologic diseases ( Site 1001)
Buenos Aires, C1118AAT
Argentina
Royal Adelaide Hospital ( Site 1104)
Adelaide, South Australia 5000
Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
Melbourne, Victoria 3021
Australia
UZ Leuven-Hematology ( Site 1200)
Leuven, Vlaams-Brabant 3000
Belgium
ZAS Cadix ( Site 1203)
Antwerp, 2030
Belgium
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo, 01246-000
Brazil
The Moncton Hospital ( Site 1414)
Moncton, New Brunswick E1C 6Z8
Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402)
Greenfield Park, Quebec J4V 2H1
Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410)
Sherbrooke, Quebec J1H 5H4
Canada
Biocenter ( Site 1507)
Concepción, Biobio 4070196
Chile
IC La Serena Research ( Site 1506)
La Serena, Coquimbo Region 1720430
Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago, Region M. de Santiago 7500653
Chile
FALP-UIDO ( Site 1500)
Santiago, Region M. de Santiago 7500921
Chile
Clínica Inmunocel ( Site 1511)
Santiago, Region M. de Santiago 7580206
Chile
Fundación Valle del Lili ( Site 1703)
Cali, Valle del Cauca Department 760032
Colombia
Hopital Claude Huriez - CHU de Lille ( Site 2107)
Lille, Nord 59037
France
Centre Hospitalier Universitaire Estaing ( Site 2105)
Clermont-Ferrand, Puy-de-Dome 63100
France
CHD Vendee ( Site 2100)
La Roche-sur-Yon, Vendee 85925
France
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
Trier, Rhineland-Palatinate 54290
Germany
Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
Leipzig, Saxony 04103
Germany
Rambam Health Care Campus ( Site 2801)
Haifa, 3109601
Israel
Hadassah Medical Center-Hemato-Oncology ( Site 2812)
Jerusalem, 9112001
Israel
Sheba Medical Center-Hemato Oncology ( Site 2809)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 2811)
Tel Aviv, 6423906
Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)
Alessandria, 15121
Italy
Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
Milan, 20132
Italy
Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
Reggio Emilia, 42123
Italy
Centro de Infusion Superare ( Site 3314)
Mexico City, Mexico City 03100
Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 3301)
Mexico City, Mexico City 03100
Mexico
Centro de Investigacion Clinica Chapultepec ( Site 3309)
Morelia, Michoacán 58260
Mexico
Auxilio Mutuo Cancer Center ( Site 3900)
San Juan, 00918
Puerto Rico
Alberts Cellular Therapy. ( Site 4401)
Pretoria, Gauteng 0181
South Africa
Groote Schuur Hospital ( Site 4400)
Cape Town, Western Cape 7925
South Africa
Haemalife ( Site 4407)
Kuilsriver, Western Cape 7580
South Africa
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)
L'Hospitalet Del Llobregat, Barcelona 08908
Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
Pozuelo de Alarcón, Madrid 28223
Spain
HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
Valencia, Valenciana, Comunitat 46010
Spain
Ege Universitesi Hastanesi ( Site 4902)
Bornova, İzmir 35100
Turkey (Türkiye)
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Tekirdağ, Tekirdas 59100
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara, 06100
Turkey (Türkiye)
Mega Medipol-Hematology ( Site 4904)
Istanbul, 34214
Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Istanbul, 34722
Turkey (Türkiye)
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
Nottingham, England NG5 1PF
United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
London-Camden, London, City of NW1 2PG
United Kingdom