Chronic Lymphocytic Leukemia Clinical Trial

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Summary

The purpose of this study is to evaluate the efficacy and safety of nemtabrutinib compared to investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) or bendamustine plus rituximab (BR) in participants with previously untreated leukemia-cll/" >CLL/SLL without 17p deletion and/or tumor protein (TP) 53 mutation. The primary hypothesis is that nemtabrutinib is superior to FCR/BR with respect to progression-free survival (PFS).

View Eligibility Criteria

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status
The ability to swallow and retain oral medication

Exclusion Criteria:

Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
History of severe bleeding disorders
Not adequately recovered from major surgery or has ongoing surgical complications

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05624554

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 84 Locations for this study

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Highlands Oncology Group ( Site 5205)
Springdale Arkansas, 72762, United States More Info
Study Coordinator
Contact
479-872-8130
Clermont Oncology Center ( Site 5224)
Clermont Florida, 34711, United States More Info
Study Coordinator
Contact
352-242-1366
Hattiesburg Clinic Hematology/Oncology ( Site 5216)
Hattiesburg Mississippi, 39401, United States More Info
Study Coordinator
Contact
601-261-1700
Medical Oncology Associates, PS ( Site 5206)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
Royal Adelaide Hospital ( Site 1105)
Adelaide South Australia, 5000, Australia
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)
Curitiba Parana, 81520, Brazil More Info
Study Coordinator
Contact
+55 41 999846033
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
Jaú Sao Paulo, 17210, Brazil More Info
Study Coordinator
Contact
5514991337515
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo Sao Paulo, 01246, Brazil More Info
Study Coordinator
Contact
+5511999014316
A. C. Camargo Cancer Center ( Site 1318)
São Paulo Sao Paulo, 01509, Brazil More Info
Study Coordinator
Contact
+551121895000
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (
Rio de Janeiro , 20231, Brazil More Info
Study Coordinator
Contact
+552199616963
Hospital Paulistano-Americas Oncologia ( Site 1302)
Sao Paulo , 01321, Brazil More Info
Study Coordinator
Contact
+5511992926463
James Lind Centro de Investigación del Cáncer ( Site 1503)
Temuco Araucania, 48008, Chile More Info
Study Coordinator
Contact
56974316500
Biocenter ( Site 1507)
Concepción Biobio, 40701, Chile More Info
Study Coordinator
Contact
56956284078
IC La Serena Research ( Site 1506)
La Serena Coquimbo, 17204, Chile More Info
Study Coordinator
Contact
+56951280903
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago Region M. De Santiago, 75006, Chile More Info
Study Coordinator
Contact
+56991612199
FALP-UIDO ( Site 1500)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56984290128
Clínica Inmunocel ( Site 1511)
Santiago Region M. De Santiago, 75802, Chile More Info
Study Coordinator
Contact
997890202
Peking University Third Hospital ( Site 1602)
Beijing Beijing, 10009, China More Info
Study Coordinator
Contact
86 13661112910
Chongqing University Cancer Hospital ( Site 1605)
Chongqing Chongqing, 40003, China More Info
Study Coordinator
Contact
+86-13527363925
Chongqing University Three Gorges Hospital ( Site 1609)
Chongqing Chongqing, 40400, China More Info
Study Coordinator
Contact
13452762769
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)
Guangzhou Guangdong, 51051, China More Info
Study Coordinator
Contact
020-61641615
Sun Yat-sen University Cancer Center ( Site 1608)
Guangzhou Guangdong, 51070, China More Info
Study Coordinator
Contact
+8613798032244
The Affiliated Hospital of Guizhou Medical University ( Site 1625)
Guiyang Guizhou, 55000, China More Info
Study Coordinator
Contact
0851-86740793
Hainan General Hospital ( Site 1603)
Haikou Hainan, 57031, China More Info
Study Coordinator
Contact
0898-68642547
Henan Cancer Hospital-hematology department ( Site 1613)
Zhengzhou Henan, 45000, China More Info
Study Coordinator
Contact
+86 13674902391
Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)
Wuhan Hubei, 43000, China More Info
Study Coordinator
Contact
027-83665006
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)
Wuhan Hubei, 43001, China More Info
Study Coordinator
Contact
027-84309723
Xiangya Hospital Central South University-Hematology department ( Site 1616)
Changsha Hunan, 41000, China More Info
Study Coordinator
Contact
0731-89753059
Hunan Cancer Hospital ( Site 1615)
Changsha Hunan, 41001, China More Info
Study Coordinator
Contact
19918803330
The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)
Suzhou Jiangsu, 21500, China More Info
Study Coordinator
Contact
13616219570
The First Affiliated Hospital of Nanchang University ( Site 1614)
Nanchang Jiangxi, 33000, China More Info
Study Coordinator
Contact
13970038386
Jiangxi Provincial Cancer Hospital ( Site 1628)
Nanchang Jiangxi, 33002, China More Info
Study Coordinator
Contact
13970880559
The First Hospital of Jilin University-Hematology ( Site 1621)
Changchun Jilin, 13002, China More Info
Study Coordinator
Contact
+86 15843073208
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)
Xi'an Shaanxi, 71006, China More Info
Study Coordinator
Contact
+029 85324421
Shaanxi provincial people's hospital ( Site 1626)
Xi'an Shaanxi, 71006, China More Info
Study Coordinator
Contact
+029 85251331
Fudan University Shanghai Cancer Center ( Site 1606)
Shanghai Shanghai, 20003, China More Info
Study Coordinator
Contact
021-64175590-85100
Shanxi Cancer Hospital ( Site 1629)
Taiyuan Shanxi, 03000, China More Info
Study Coordinator
Contact
+86 138 3515 8122
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)
Tianjin Tianjin, 30006, China More Info
Study Coordinator
Contact
+86 22 2334 0123
Institute of hematology&blood disease hospital-Hematology ( Site 1600)
Tianjin Tianjin, 30163, China More Info
Study Coordinator
Contact
022-23909083
The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)
Hangzhou Zhejiang, 31000, China More Info
Study Coordinator
Contact
057187236898
Clini Salud ( Site 1700)
Envigado Antioquia, 05542, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 1707)
Medellin Antioquia, 05003, Colombia More Info
Study Coordinator
Contact
3128466807
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)
Valledupar Cesar, 20000, Colombia More Info
Study Coordinator
Contact
3112620177
Oncologos del Occidente ( Site 1706)
Pereira Risaralda, 66000, Colombia More Info
Study Coordinator
Contact
3005088515
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
Aarhus Midtjylland, 8200, Denmark More Info
Study Coordinator
Contact
21391053
Aalborg Universitetshospital, Syd ( Site 1901)
Aalborg Nordjylland, 9000, Denmark More Info
Study Coordinator
Contact
+4597660000
Odense Universitetshospital ( Site 1900)
Odense Syddanmark, 5000, Denmark More Info
Study Coordinator
Contact
+4566113333
Vejle Sygehus ( Site 1903)
Vejle Syddanmark, 7100, Denmark More Info
Study Coordinator
Contact
+45 79406772
CELAN,S.A ( Site 2403)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+ 502 5200-2329
Oncomedica-Guatemala ( Site 2402)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
50222540304
MEDI-K CAYALA ( Site 2401)
Guatemala , 01016, Guatemala More Info
Study Coordinator
Contact
+50255505555
Queen Mary Hospital ( Site 2500)
Hksar , , Hong Kong More Info
Study Coordinator
Contact
+85222551654
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
Székesfehérvár Fejer, 8000, Hungary More Info
Study Coordinator
Contact
36305828330
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)
Eger Heves, 3300, Hungary More Info
Study Coordinator
Contact
0036704223242
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary More Info
Study Coordinator
Contact
42599700
Hospital Sultanah Aminah ( Site 3203)
Johor Bahru Johor, 80100, Malaysia More Info
Study Coordinator
Contact
60126097954
Hospital Ampang ( Site 3202)
Ampang Selangor, 68000, Malaysia More Info
Study Coordinator
Contact
+60126188434
Health Pharma Professional Research S.A. de C.V: ( Site 3301)
Ciudad de México Distrito Federal, 03100, Mexico More Info
Study Coordinator
Contact
5538173808
Centro de Investigacion Clinica Chapultepec ( Site 3309)
Morelia Michoacan, 58260, Mexico More Info
Study Coordinator
Contact
4431478545
Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla
Lublin Lubelskie, 20-08, Poland More Info
Study Coordinator
Contact
815345468
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
225462223
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
Gdansk Pomorskie, 80-95, Poland More Info
Study Coordinator
Contact
+48585844255
Pratia Onkologia Katowice ( Site 3705)
Katowice Slaskie, 40-51, Poland More Info
Study Coordinator
Contact
+48600388282
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
Kielce Swietokrzyskie, 25-73, Poland More Info
Study Coordinator
Contact
48793907806
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37
Olsztyn Warminsko-mazurskie, 10-22, Poland More Info
Study Coordinator
Contact
+48895398756
Spitalul Clinic Colțea ( Site 4000)
București Bucuresti, 03017, Romania More Info
Study Coordinator
Contact
0040722661228
Spitalul Clinic Colțea ( Site 4001)
București Bucuresti, 03017, Romania More Info
Study Coordinator
Contact
0040722833451
Institutul Oncologic Cluj ( Site 4002)
Cluj , 40001, Romania More Info
Study Coordinator
Contact
0741337480
National Cancer Centre Singapore ( Site 4200)
Singapore Central Singapore, 16858, Singapore More Info
Study Coordinator
Contact
+65 6436 8088
Tan Tock Seng Hospital ( Site 4202)
Singapore Central Singapore, 30843, Singapore More Info
Study Coordinator
Contact
+65 6359 6555
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Centurion Gauteng, 0181, South Africa More Info
Study Coordinator
Contact
27129932555
Wits Clinical Research ( Site 4403)
Johannesburg Gauteng, 1864, South Africa More Info
Study Coordinator
Contact
27119836501
Groote Schuur Hospital-Clinical Haematology ( Site 4400)
Cape Town Western Cape, 7925, South Africa More Info
Study Coordinator
Contact
0727689024
Haemalife ( Site 4407)
Kuilsriver Western Cape, 7580, South Africa More Info
Study Coordinator
Contact
+27219006277
Constantiaberg Haematology ( Site 4408)
Plumstead Western Cape, 7800, South Africa More Info
Study Coordinator
Contact
0217616600
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
Kaohsiung , 83301, Taiwan More Info
Study Coordinator
Contact
+886 978839894
National Cheng Kung University Hospital ( Site 4701)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
88662353535
National Taiwan University Hospital ( Site 4704)
Taipei , 10022, Taiwan More Info
Study Coordinator
Contact
+886-2-23123456 ext.18563629
Mega Medipol-Hematology ( Site 4904)
Stanbul Istanbul, 34214, Turkey More Info
Study Coordinator
Contact
905437870708
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Suleymanpasa Tekirdas, 59100, Turkey More Info
Study Coordinator
Contact
+905324333676
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara , 06100, Turkey More Info
Study Coordinator
Contact
+90 505 502 50 50
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Istanbul , 34722, Turkey More Info
Study Coordinator
Contact
+905324089525
Ege Universitesi Hastanesi ( Site 4902)
İzmir , 35100, Turkey More Info
Study Coordinator
Contact
+905325566128
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
Cherkassy Cherkaska Oblast, 18009, Ukraine More Info
Study Coordinator
Contact
+380634253209
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)
Ivano-Frankivsk Ivano-Frankivska Oblast, 76008, Ukraine More Info
Study Coordinator
Contact
380974668727
Nonprofit Organization National Cancer Institute ( Site 5103)
Kyiv Kyivska Oblast, 03022, Ukraine More Info
Study Coordinator
Contact
380672091427
Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr
Lviv Lvivska Oblast, 79057, Ukraine More Info
Study Coordinator
Contact
+380 987529801
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
Kyiv , 03115, Ukraine More Info
Study Coordinator
Contact
380 67 4443800
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)
Kyiv , 04112, Ukraine More Info
Study Coordinator
Contact
+380509105840

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05624554

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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