Clinical trial NCT05624554: 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)
Official title: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).


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

Primary outcomes:
measure: Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 49 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 94 months
measure: Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
timeFrame: Up to approximately 36 months
measure: Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
timeFrame: Up to approximately 94 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 94 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 94 months
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group ( Site 5205)
state: Arkansas
city: Clermont
country: United States
facility: Clermont Oncology Center ( Site 5224)
state: Florida
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 5216)
state: Mississippi
city: Spokane
country: United States
facility: Medical Oncology Associates, PS ( Site 5206)
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 1105)
state: South Australia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)
state: Parana
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 1318)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (
city: Sao Paulo
country: Brazil
facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano-Americas Oncologia ( Site 1302)
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403)
state: Sofia (stolitsa)
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404)
city: Plovdiv
country: Bulgaria
facility: Medical Centre Pratia Clinic EOOD ( Site 6406)
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400)
city: Vratsa
country: Bulgaria
facility: Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402)
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 1503)
state: Araucania
city: Concepcion
country: Chile
facility: Biocenter ( Site 1507)
state: Biobio
city: La Serena.
country: Chile
facility: IC La Serena Research ( Site 1506)
state: Coquimbo
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 1500)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel ( Site 1511)
state: Region M. De Santiago
city: Beijing
country: China
facility: Peking University Third Hospital ( Site 1602)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 1605)
state: Chongqing
city: Wanzhou
country: China
facility: Chongqing University Three Gorges Hospital ( Site 1609)
state: Chongqing
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 1608)
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University ( Site 1625)
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital ( Site 1603)
state: Hainan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-hematology department ( Site 1613)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Hematology department ( Site 1616)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1615)
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 1614)
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital ( Site 1628)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University-Hematology ( Site 1621)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi provincial people's hospital ( Site 1626)
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 1606)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 1629)
state: Shanxi
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital ( Site 1600)
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)
state: Zhejiang
city: Envigado
country: Colombia
facility: Clini Salud ( Site 1700)
state: Antioquia
city: Medellin
country: Colombia
facility: Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)
state: Cesar
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 1706)
state: Risaralda
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd ( Site 1901)
state: Nordjylland
city: Odense C
country: Denmark
facility: Odense Universitetshospital ( Site 1900)
state: Syddanmark
city: Vejle
country: Denmark
facility: Vejle Sygehus ( Site 1903)
state: Syddanmark
city: Guatemala
country: Guatemala
facility: MEDI-K ( Site 2401)
city: Guatemala
country: Guatemala
facility: CELAN,S.A ( Site 2403)
city: Guatemala
country: Guatemala
facility: Oncomedica-Guatemala ( Site 2402)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 2500)
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
state: Fejer
city: Eger
country: Hungary
facility: Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)
state: Heves
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
state: Szabolcs-Szatmar-Bereg
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3
state: Kauno Apskritis
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah ( Site 3203)
state: Johor
city: Ampang
country: Malaysia
facility: Hospital Ampang ( Site 3202)
state: Selangor
city: Ciudad de México
country: Mexico
facility: Centro de Infusion Superare ( Site 3314)
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V: ( Site 3301)
state: Distrito Federal
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec ( Site 3309)
state: Michoacan
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization ( Site 3313)
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla
state: Lubelskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
state: Pomorskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice ( Site 3705)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
state: Swietokrzyskie
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37
state: Warminsko-mazurskie
city: București
country: Romania
facility: Spitalul Clinic Colțea ( Site 4000)
state: Bucuresti
city: București
country: Romania
facility: Spitalul Clinic Colțea ( Site 4001)
state: Bucuresti
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj ( Site 4002)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 4200)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital ( Site 4202)
state: Central Singapore
city: Centurion
country: South Africa
facility: Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 4403)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital-Clinical Haematology ( Site 4400)
state: Western Cape
city: Kuilsriver
country: South Africa
facility: Haemalife ( Site 4407)
state: Western Cape
city: Plumstead
country: South Africa
facility: Constantiaberg Haematology ( Site 4408)
state: Western Cape
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 4701)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 4704)
city: Stanbul
country: Turkey
facility: Mega Medipol-Hematology ( Site 4904)
state: Istanbul
city: Suleymanpasa
country: Turkey
facility: Namik Kemal University Medical Faculty-Hematology ( Site 4912)
state: Tekirdas
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi ( Site 4902)
city: Cherkassy
country: Ukraine
facility: MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
state: Cherkaska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)
state: Ivano-Frankivska Oblast
city: Kyiv
country: Ukraine
facility: Nonprofit Organization National Cancer Institute ( Site 5103)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr
state: Lvivska Oblast
city: Kyiv
country: Ukraine
facility: National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
city: Kyiv
country: Ukraine
facility: Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: