Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief 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)
Official Title: 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)
Study ID: NCT06136559
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Parkview Research Center at Parkview Regional Medical Center ( Site 0002), Fort Wayne, Indiana, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017), Iowa City, Iowa, United States
Summit Medical Group Cancer Center ( Site 0007), Florham Park, New Jersey, United States
Cancer Care Associates Of York ( Site 0005), York, Pennsylvania, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010), Spokane, Washington, United States
University Hospital and UW Health Clinics ( Site 0006), Madison, Wisconsin, United States
Hospital 9 De Julho ( Site 2206), São Paulo, Sao Paulo, Brazil
Hospital Paulistano-Americas Oncologia ( Site 2202), Sao Paulo, , Brazil
William Osler Health System ( Site 0103), Brampton, Ontario, Canada
The Ottawa Hospital - General Campus ( Site 0102), Ottawa, Ontario, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski (, Rimouski, Quebec, Canada
FALP-UIDO ( Site 2300), Santiago, Region M. De Santiago, Chile
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 2310), Santiago, Region M. De Santiago, Chile
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006), Guangzhou, Guangdong, China
Liuzhou People's Hospital ( Site 2029), Liuzhou, Guangxi, China
The Affiliated Hospital of Guizhou Medical University ( Site 2024), Guiyang, Guizhou, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2016), Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015), Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University ( Site 2023), Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital ( Site 2009), Nanchang, Jiangxi, China
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005), Tianjin, Tianjin, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014), Urumqi, Xinjiang, China
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503), Haifa, , Israel
Bnai Zion Medical Center ( Site 1505), Haifa, , Israel
Hadassah Medical Center-Hemato-Oncology ( Site 1500), Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 1501), Ramat Gan, , Israel
Yitzhak Shamir Medical Center. ( Site 1506), Zerifin, , Israel
Kobe City Medical Center General Hospital ( Site 1910), Kobe, Hyogo, Japan
Tohoku University Hospital ( Site 1901), Sendai, Miyagi, Japan
Shimane University Hospital ( Site 1911), Izumo, Shimane, Japan
Japanese Foundation for Cancer Research ( Site 1906), Koto, Tokyo, Japan
Chiba cancer center ( Site 1905), Chiba, , Japan
Osaka Red Cross Hospital ( Site 1908), Osaka, , Japan
Yamagata University Hospital ( Site 1902), Yamagata, , Japan
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 1700), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1701), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1703), Taoyuan, , Taiwan
Southmead Hospital ( Site 3010), Bristol, Bristol, City Of, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006), London, London, City Of, United Kingdom
The Churchill Hospital ( Site 3007), Oxford, Oxfordshire, United Kingdom
GenesisCare - Cambridge ( Site 3001), Newmarket, Suffolk, United Kingdom
GenesisCare - Windsor ( Site 3002), Windsor, Windsor And Maidenhead, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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