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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 16, 2023

Primary Completion Date

May 19, 2027

Study Completion Date

March 17, 2031

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Nemtabrutinib

65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met.

DRUG

Fludarabine

25 mg/m\^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.

DRUG

Cyclophosphamide

250 mg/m\^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.

DRUG

Bendamustine

Administered via IV infusion on Days 1 and 2 of each 28-day cycle up to 6 cycles. The first dose is given as 70 to 90 mg/m\^2. Subsequent doses may be escalated up to 90 mg/m\^2, if applicable and as per local guidelines.

BIOLOGICAL

Rituximab

Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.

BIOLOGICAL

Truxima

Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.

BIOLOGICAL

Ruxience

Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.

BIOLOGICAL

Riabni

Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.

Trial Locations (97)

704

National Cheng Kung University Hospital ( Site 4701), Tainan City

1797

Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403), Sofia

1864

Wits Clinical Research ( Site 4403), Johannesburg

3000

"Multriprofile Hospital for Active Treatment Hristo Botev ( Site 6402)", Vratsa

3300

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608), Eger

4002

"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD ( Site 6404)", Plovdiv

4003

Medical Centre Pratia Clinic EOOD ( Site 6406), Plovdiv

4400

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602), Nyíregyháza

5000

Royal Adelaide Hospital ( Site 1105), Adelaide

Odense Universitetshospital ( Site 1900), Odense C

6003

"UMHAT Prof. Dr. Stoyan KirkovichAD-Clinical Hematology ( Site 6400)", Stara Zagora

7100

Vejle Sygehus ( Site 1903), Vejle

7580

Haemalife ( Site 4407), Kuilsriver

7800

Constantiaberg Haematology ( Site 4408), Plumstead

7925

Groote Schuur Hospital-Clinical Haematology ( Site 4400), Cape Town

8000

Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609), Székesfehérvár

8200

Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902), Aarhus

9000

Aalborg Universitetshospital, Syd ( Site 1901), Aalborg

10002

National Taiwan University Hospital ( Site 4704), Taipei

18009

MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 5106), Cherkassy

34214

Mega Medipol-Hematology ( Site 4904), Stanbul

34711

Clermont Oncology Center ( Site 5224), Clermont

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906), Istanbul

35100

Ege Universitesi Hastanesi ( Site 4902), Izmir

39401

Hattiesburg Clinic Hematology/Oncology ( Site 5216), Hattiesburg

50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3100), Kaunas

58260

Centro de Investigacion Clinica Chapultepec ( Site 3309), Morelia

59100

Namik Kemal University Medical Faculty-Hematology ( Site 4912), Suleymanpasa

68000

Hospital Ampang ( Site 3202), Ampang

Oaxaca Site Management Organization ( Site 3313), Oaxaca City

72762

Highlands Oncology Group ( Site 5205), Springdale

76008

"Communal non-profit enterprise Regional clinical hospital o-Hematology Department ( Site 5113)", Ivano-Frankivsk

79057

Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr ( Site 5105), Lviv

80100

Hospital Sultanah Aminah ( Site 3203), Johor Bahru

83301

Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700), Kaohsiung City

99208

Medical Oncology Associates, PS ( Site 5206), Spokane

100191

Peking University Third Hospital ( Site 1602), Beijing

130021

The First Hospital of Jilin University-Hematology ( Site 1621), Changchun

168583

National Cancer Centre Singapore ( Site 4200), Singapore

200001

Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704), Valledupar

200032

Fudan University Shanghai Cancer Center ( Site 1606), Shanghai

215006

The First Affiliated Hospital of Soochow University-hematology department ( Site 1612), Suzhou

300020

Institute of hematology&blood disease hospital ( Site 1600), Tianjin

300060

Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604), Tianjin

308433

Tan Tock Seng Hospital ( Site 4202), Singapore

310003

The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611), Hangzhou

330006

The First Affiliated Hospital of Nanchang University ( Site 1614), Nanchang

330029

Jiangxi Provincial Cancer Hospital ( Site 1628), Nanchang

400015

Institutul Oncologic Cluj ( Site 4002), Cluj-Napoca

400030

Chongqing University Cancer Hospital ( Site 1605), Chongqing

404000

Chongqing University Three Gorges Hospital ( Site 1609), Chongqing

410008

Xiangya Hospital Central South University-Hematology department ( Site 1616), Changsha

410013

Hunan Cancer Hospital ( Site 1615), Changsha

430000

Tongji Hospital Tongji Medical,Science & Technology ( Site 1619), Wuhan

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618), Wuhan

450008

Henan Cancer Hospital-hematology department ( Site 1613), Zhengzhou

510515

Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607), Guangzhou

510700

Sun Yat-sen University Cancer Center ( Site 1608), Guangzhou

550004

The Affiliated Hospital of Guizhou Medical University ( Site 1625), Guiyang

570311

Hainan General Hospital ( Site 1603), Haikou

660001

Oncologos del Occidente ( Site 1706), Pereira

710061

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617), Xi'an

710068

Shaanxi provincial people's hospital ( Site 1626), Xi'an

1720430

IC La Serena Research ( Site 1506), La Serena

4070196

Biocenter ( Site 1507), Concepción

4800827

James Lind Centro de Investigacion del Cancer ( Site 1503), Temuco

7500653

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509), Santiago

7500921

FALP-UIDO ( Site 1500), Santiago

7580206

Clínica Inmunocel ( Site 1511), Santiago

81520-060

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317), Curitiba

17210-120

Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304), Jaú

01525-001

A. C. Camargo Cancer Center ( Site 1318), São Paulo

20231-050

Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319), Rio de Janeiro

01246-000

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308), São Paulo

01321-001

Hospital Paulistano-Americas Oncologia ( Site 1302), São Paulo

030000

Shanxi Cancer Hospital ( Site 1629), Taiyuan

055422

Clini Salud ( Site 1700), Envigado

050030

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707), Medellín

01009

MEDI-K ( Site 2401), Guatemala City

01010

CELAN,S.A ( Site 2403), Guatemala City

Oncomedica ( Site 2402), Guatemala City

Unknown

Queen Mary Hospital ( Site 2500), Hksar

03100

Centro de Infusion Superare ( Site 3314), Mexico City

Health Pharma Professional Research S.A. de C.V: ( Site 3301), Mexico City

20-081

Uniwersytecki Szpital Kliniczny nr 1 w Lublinie ( Site 3710), Lublin

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 3701), Warsaw

80-952

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702), Gdansk

40-519

Pratia Onkologia Katowice ( Site 3705), Katowice

10-228

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 3704), Olsztyn

25-734

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 3711), Kielce

030171

Spitalul Clinic Colțea ( Site 4000), Bucharest

Spitalul Clinic Colțea ( Site 4001), Bucharest

0181

Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401), Centurion

06100

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913), Ankara

03022

Nonprofit Organization National Cancer Institute ( Site 5103), Kyiv

03115

SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 5101), Kyiv

04112

Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111), Kyiv

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter