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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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