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)

April 24, 2024 updated by: Merck Sharp & Dohme LLC

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

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 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Completed
        • Royal Adelaide Hospital ( Site 1105)
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Recruiting
        • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (
        • Contact:
          • Study Coordinator
          • Phone Number: +552199616963
      • Sao Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano-Americas Oncologia ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511992926463
    • Parana
      • Curitiba, Parana, Brazil, 81520060
        • Recruiting
        • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 41 999846033
    • Sao Paulo
      • Jaú, Sao Paulo, Brazil, 17210-120
        • Recruiting
        • Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 5514991337515
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511999014316
      • São Paulo, Sao Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center ( Site 1318)
        • Contact:
          • Study Coordinator
          • Phone Number: +551121895000
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigación del Cáncer ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 56974316500
    • Biobio
      • Concepción, Biobio, Chile, 4070196
        • Recruiting
        • Biocenter ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: 56956284078
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +56951280903
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 56984290128
      • Santiago, Region M. De Santiago, Chile, 7580206
        • Recruiting
        • Clínica Inmunocel ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: 997890202
  • China
    • Beijing
      • Beijing, Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 13661112910
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +86-13527363925
      • Wanzhou, Chongqing, China, 404199
        • Recruiting
        • Chongqing Three Gorges Central Hospital ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: 13452762769
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-61641615
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613798032244
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University ( Site 1625)
        • Contact:
          • Study Coordinator
          • Phone Number: 0851-86740793
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan General Hospital ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 0898-68642547
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital-hematology department ( Site 1613)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13674902391
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-84309723
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83665006
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University-Hematology department ( Site 1616)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89753059
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 1615)
        • Contact:
          • Study Coordinator
          • Phone Number: 19918803330
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)
        • Contact:
          • Study Coordinator
          • Phone Number: 13616219570
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Provincial Cancer Hospital ( Site 1628)
        • Contact:
          • Study Coordinator
          • Phone Number: 13970880559
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 1614)
        • Contact:
          • Study Coordinator
          • Phone Number: 13970038386
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University-Hematology ( Site 1621)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 15843073208
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi provincial people's hospital ( Site 1626)
        • Contact:
          • Study Coordinator
          • Phone Number: +029 85251331
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)
        • Contact:
          • Study Coordinator
          • Phone Number: +029 85324421
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-64175590-85100
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital ( Site 1629)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 138 3515 8122
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 22 2334 0123
      • Tianjin, Tianjin, China, 301636
        • Recruiting
        • Institute of hematology&blood disease hospital-Hematology ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: 022-23909083
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)
        • Contact:
          • Study Coordinator
          • Phone Number: 057187236898
  • Colombia
    • Antioquia
      • Envigado, Antioquia, Colombia, 055422
        • Completed
        • Clini Salud ( Site 1700)
      • Medellin, Antioquia, Colombia, 050030
        • Recruiting
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: 3128466807
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: 3112620177
    • Risaralda
      • Pereira, Risaralda, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: 3005088515
  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 21391053
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: +4597660000
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +4566113333
      • Vejle, Syddanmark, Denmark, 7100
        • Recruiting
        • Vejle Sygehus ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 79406772
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Recruiting
        • CELAN,S.A ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: + 502 5200-2329
      • Guatemala, Guatemala, 01010
        • Recruiting
        • Oncomedica-Guatemala ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: 50222540304
      • Guatemala, Guatemala, 01016
        • Recruiting
        • MEDI-K CAYALA ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +50255505555
  • Hong Kong
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: +85222551654
  • Hungary
    • Fejer
      • Székesfehérvár, Fejer, Hungary, 8000
        • Recruiting
        • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
        • Contact:
          • Study Coordinator
          • Phone Number: 36305828330
    • Heves
      • Eger, Heves, Hungary, 3300
        • Recruiting
        • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: 0036704223242
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Recruiting
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 42599700
  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Recruiting
        • Hospital Sultanah Aminah ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: 60126097954
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Recruiting
        • Hospital Ampang ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +60126188434
  • Mexico
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A. de C.V: ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: 5538173808
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Recruiting
        • Centro de Investigacion Clinica Chapultepec ( Site 3309)
        • Contact:
          • Study Coordinator
          • Phone Number: 4431478545
  • Poland
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-081
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla
        • Contact:
          • Study Coordinator
          • Phone Number: 815345468
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
        • Contact:
          • Study Coordinator
          • Phone Number: 225462223
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
        • Contact:
          • Study Coordinator
          • Phone Number: +48585844255
    • Slaskie
      • Katowice, Slaskie, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice ( Site 3705)
        • Contact:
          • Study Coordinator
          • Phone Number: +48600388282
    • Swietokrzyskie
      • Kielce, Swietokrzyskie, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
        • Contact:
          • Study Coordinator
          • Phone Number: 48793907806
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-228
        • Recruiting
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37
        • Contact:
          • Study Coordinator
          • Phone Number: +48895398756
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital ( Site 4202)
        • Contact:
          • Study Coordinator
          • Phone Number: +65 6359 6555
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 4200)
        • Contact:
          • Study Coordinator
          • Phone Number: +65 6436 8088
  • South Africa
    • Gauteng
      • Centurion, Gauteng, South Africa, 0181
        • Recruiting
        • Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
        • Contact:
          • Study Coordinator
          • Phone Number: 27129932555
      • Johannesburg, Gauteng, South Africa, 1864
        • Recruiting
        • Wits Clinical Research ( Site 4403)
        • Contact:
          • Study Coordinator
          • Phone Number: 27119836501
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Groote Schuur Hospital-Clinical Haematology ( Site 4400)
        • Contact:
          • Study Coordinator
          • Phone Number: 0727689024
      • Kuilsriver, Western Cape, South Africa, 7580
        • Recruiting
        • Haemalife ( Site 4407)
        • Contact:
          • Study Coordinator
          • Phone Number: +27219006277
      • Plumstead, Western Cape, South Africa, 7800
        • Recruiting
        • Constantiaberg Haematology ( Site 4408)
        • Contact:
          • Study Coordinator
          • Phone Number: 0217616600
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
        • Contact:
          • Study Coordinator
          • Phone Number: +886 978839894
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 4701)
        • Contact:
          • Study Coordinator
          • Phone Number: 88662353535
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital ( Site 4704)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-23123456 ext.18563629
  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 505 502 50 50
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324089525
      • İzmir, Turkey, 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 4902)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325566128
    • Istanbul
      • Stanbul, Istanbul, Turkey, 34214
        • Recruiting
        • Mega Medipol-Hematology ( Site 4904)
        • Contact:
          • Study Coordinator
          • Phone Number: 905437870708
    • Tekirdas
      • Suleymanpasa, Tekirdas, Turkey, 59100
        • Recruiting
        • Namik Kemal University Medical Faculty-Hematology ( Site 4912)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324333676
  • Ukraine
      • Kyiv, Ukraine, 04112
        • Recruiting
        • Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)
        • Contact:
          • Study Coordinator
          • Phone Number: +380509105840
      • Kyiv, Ukraine, 03115
        • Recruiting
        • National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
        • Contact:
          • Study Coordinator
          • Phone Number: 380 67 4443800
    • Cherkaska Oblast
      • Cherkassy, Cherkaska Oblast, Ukraine, 18009
        • Recruiting
        • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
        • Contact:
          • Study Coordinator
          • Phone Number: +380634253209
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
        • Recruiting
        • Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)
        • Contact:
          • Study Coordinator
          • Phone Number: 380974668727
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • Recruiting
        • Nonprofit Organization National Cancer Institute ( Site 5103)
        • Contact:
          • Study Coordinator
          • Phone Number: 380672091427
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79057
        • Recruiting
        • Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr
        • Contact:
          • Study Coordinator
          • Phone Number: +380 987529801
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group ( Site 5205)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-872-8130
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center ( Site 5224)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-242-1366
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic Hematology/Oncology ( Site 5216)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-261-1700
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates, PS ( Site 5206)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-462-2273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemtabrutinib
Administered daily via oral tablet.
Drug: Nemtabrutinib
65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met
Other Names:
  • MK-1026
Active Comparator: FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
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
Other Names:
  • RITUXAN®
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
Other Names:
  • Rituximab biosimilar
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
Other Names:
  • Rituximab biosimilar
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
Other Names:
  • Rituximab biosimilar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 49 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR).
Up to approximately 49 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 94 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 94 months
Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
Time Frame: Up to approximately 36 months
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or Partial response (PR), per iwCLL criteria 2018 as assessed by BICR.
Up to approximately 36 months
Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
Time Frame: Up to approximately 94 months
For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL criteria as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first.
Up to approximately 94 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 94 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 94 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 94 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 94 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

May 19, 2027

Study Completion (Estimated)

March 17, 2031

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-008
  • 2022-500164-35-00 (Registry Identifier: EU CT)
  • MK-1026-008 (Other Identifier: Merck)
  • 2021-006593-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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