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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)

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nemtabrutinib
Fludarabine
Cyclophosphamide
Bendamustine
Rituximab
Truxima
Ruxience
Riabni
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Highlands Oncology Group ( Site 5205)Recruiting
  • Hattiesburg Clinic Hematology/Oncology ( Site 5216)Recruiting
  • Medical Oncology Associates, PS ( Site 5206)Recruiting
  • Royal Adelaide Hospital ( Site 1105)Recruiting
  • Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)Recruiting
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)Recruiting
  • Hospital Paulistano-Americas Oncologia ( Site 1302)Recruiting
  • James Lind Centro de Investigación del Cáncer ( Site 1503)Recruiting
  • Biocenter ( Site 1507)Recruiting
  • IC La Serena Research ( Site 1506)Recruiting
  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)Recruiting
  • FALP-UIDO ( Site 1500)Recruiting
  • Peking University Third Hospital ( Site 1602)Recruiting
  • Chongqing University Cancer Hospital ( Site 1605)Recruiting
  • Chongqing Three Gorges Central Hospital ( Site 1609)Recruiting
  • Sun Yat-sen University Cancer Center ( Site 1608)Recruiting
  • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)Recruiting
  • The Affiliated Hospital of Guizhou Medical University ( Site 1625)Recruiting
  • Hainan General Hospital ( Site 1603)Recruiting
  • Henan Cancer Hospital-hematology department ( Site 1613)Recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)Recruiting
  • Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)Recruiting
  • The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)Recruiting
  • The First Affiliated Hospital of Nanchang University ( Site 1614)Recruiting
  • Jiangxi Provincial Cancer Hospital ( Site 1628)Recruiting
  • The First Hospital of Jilin University-Hematology ( Site 1621)Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)Recruiting
  • Shaanxi provincial people's hospital ( Site 1626)Recruiting
  • Fudan University Shanghai Cancer Center ( Site 1606)Recruiting
  • Shanxi Cancer Hospital ( Site 1629)Recruiting
  • Institute of hematology&blood disease hospital-Hematology ( Site 1600)Recruiting
  • Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)Recruiting
  • The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)Recruiting
  • Clini Salud ( Site 1700)Recruiting
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 1707)Recruiting
  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)Recruiting
  • Oncologos del Occidente ( Site 1706)Recruiting
  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)Recruiting
  • Aalborg Universitetshospital, Syd ( Site 1901)Recruiting
  • Odense Universitetshospital ( Site 1900)Recruiting
  • Vejle Sygehus ( Site 1903)Recruiting
  • CELAN,S.A ( Site 2403)Recruiting
  • Oncomedica-Guatemala ( Site 2402)Recruiting
  • MEDI-K CAYALA ( Site 2401)Recruiting
  • Queen Mary Hospital ( Site 2500)Recruiting
  • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)Recruiting
  • Markhot Ferenc Oktatokorhaz es Rendelointezet ( Site 2608)Recruiting
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)Recruiting
  • Hospital Sultanah Aminah ( Site 3203)Recruiting
  • Hospital Ampang ( Site 3202)Recruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow TransplaRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( SRecruiting
  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)Recruiting
  • Pratia Onkologia Katowice ( Site 3705)Recruiting
  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji SRecruiting
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37Recruiting
  • National Cancer Centre Singapore ( Site 4200)Recruiting
  • Tan Tock Seng Hospital ( Site 4202)Recruiting
  • Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)Recruiting
  • Wits Clinical Research ( Site 4403)Recruiting
  • Haemalife ( Site 4407)Recruiting
  • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)Recruiting
  • National Cheng Kung University Hospital ( Site 4701)Recruiting
  • National Taiwan University Hospital ( Site 4704)Recruiting
  • Mega Medipol-Hematology ( Site 4904)Recruiting
  • Namik Kemal University Medical Faculty-Hematology ( Site 4912)Recruiting
  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)Recruiting
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)Recruiting
  • Ege Universitesi Hastanesi ( Site 4902)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nemtabrutinib

FCR or BR

Arm Description

Administered daily via oral tablet.

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
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).

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
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.
Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
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.
Number of Participants Who Experience an Adverse Event (AE)
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.
Number of Participants Who Discontinue Study Treatment Due to an AE
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.

Full Information

First Posted
November 14, 2022
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05624554
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
May 19, 2027 (Anticipated)
Study Completion Date
March 17, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nemtabrutinib
Arm Type
Experimental
Arm Description
Administered daily via oral tablet.
Arm Title
FCR or BR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nemtabrutinib
Other Intervention Name(s)
MK-1026
Intervention Description
65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
25 mg/m^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
250 mg/m^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
RITUXAN®
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Truxima
Other Intervention Name(s)
Rituximab biosimilar
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Ruxience
Other Intervention Name(s)
Rituximab biosimilar
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Riabni
Other Intervention Name(s)
Rituximab biosimilar
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
Description
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).
Time Frame
Up to approximately 49 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 94 months
Title
Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 36 months
Title
Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 94 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 94 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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.
Time Frame
Up to approximately 94 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group ( Site 5205)
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
479-872-8130
Facility Name
Hattiesburg Clinic Hematology/Oncology ( Site 5216)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
601-261-1700
Facility Name
Medical Oncology Associates, PS ( Site 5206)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-462-2273
Facility Name
Royal Adelaide Hospital ( Site 1105)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61-8-8222-6934
Facility Name
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
City
Jaú
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5514991337515
Facility Name
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5511999014316
Facility Name
Hospital Paulistano-Americas Oncologia ( Site 1302)
City
Sao Paulo
ZIP/Postal Code
01321-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5511992926463
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 1503)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56974316500
Facility Name
Biocenter ( Site 1507)
City
Concepción
State/Province
Biobio
ZIP/Postal Code
4070196
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56956284078
Facility Name
IC La Serena Research ( Site 1506)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56951280903
Facility Name
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
997890202
Facility Name
FALP-UIDO ( Site 1500)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56984290128
Facility Name
Peking University Third Hospital ( Site 1602)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
86 13661112910
Facility Name
Chongqing University Cancer Hospital ( Site 1605)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86-13527363925
Facility Name
Chongqing Three Gorges Central Hospital ( Site 1609)
City
Wanzhou
State/Province
Chongqing
ZIP/Postal Code
404199
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13452762769
Facility Name
Sun Yat-sen University Cancer Center ( Site 1608)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613798032244
Facility Name
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-61641615
Facility Name
The Affiliated Hospital of Guizhou Medical University ( Site 1625)
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0851-86740793
Facility Name
Hainan General Hospital ( Site 1603)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0898-68642547
Facility Name
Henan Cancer Hospital-hematology department ( Site 1613)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13674902391
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
027-84309723
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
027-83665006
Facility Name
The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13616219570
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 1614)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13970038386
Facility Name
Jiangxi Provincial Cancer Hospital ( Site 1628)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13970880559
Facility Name
The First Hospital of Jilin University-Hematology ( Site 1621)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 15843073208
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+029 85324421
Facility Name
Shaanxi provincial people's hospital ( Site 1626)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+029 85251331
Facility Name
Fudan University Shanghai Cancer Center ( Site 1606)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-64175590-85100
Facility Name
Shanxi Cancer Hospital ( Site 1629)
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 138 3515 8122
Facility Name
Institute of hematology&blood disease hospital-Hematology ( Site 1600)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23909083
Facility Name
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 22 2334 0123
Facility Name
The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
057187236898
Facility Name
Clini Salud ( Site 1700)
City
Envigado
State/Province
Antioquia
ZIP/Postal Code
055422
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
43016429
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 1707)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3128466807
Facility Name
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3112620177
Facility Name
Oncologos del Occidente ( Site 1706)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3005088515
Facility Name
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
21391053
Facility Name
Aalborg Universitetshospital, Syd ( Site 1901)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4597660000
Facility Name
Odense Universitetshospital ( Site 1900)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4566113333
Facility Name
Vejle Sygehus ( Site 1903)
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 79406772
Facility Name
CELAN,S.A ( Site 2403)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 502 5200-2329
Facility Name
Oncomedica-Guatemala ( Site 2402)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50222540304
Facility Name
MEDI-K CAYALA ( Site 2401)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50255505555
Facility Name
Queen Mary Hospital ( Site 2500)
City
Hksar
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85222551654
Facility Name
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
City
Székesfehérvár
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36305828330
Facility Name
Markhot Ferenc Oktatokorhaz es Rendelointezet ( Site 2608)
City
Eger
State/Province
Heves
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0036704223242
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
42599700
Facility Name
Hospital Sultanah Aminah ( Site 3203)
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
60126097954
Facility Name
Hospital Ampang ( Site 3202)
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60126188434
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
815345468
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
225462223
Facility Name
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48585844255
Facility Name
Pratia Onkologia Katowice ( Site 3705)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48600388282
Facility Name
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48793907806
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48895398756
Facility Name
National Cancer Centre Singapore ( Site 4200)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+65 6436 8088
Facility Name
Tan Tock Seng Hospital ( Site 4202)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+65 6359 6555
Facility Name
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27129932555
Facility Name
Wits Clinical Research ( Site 4403)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1864
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27119836501
Facility Name
Haemalife ( Site 4407)
City
Kuilsriver
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27219006277
Facility Name
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886 978839894
Facility Name
National Cheng Kung University Hospital ( Site 4701)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88662353535
Facility Name
National Taiwan University Hospital ( Site 4704)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-23123456 ext.18563629
Facility Name
Mega Medipol-Hematology ( Site 4904)
City
Stanbul
State/Province
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905437870708
Facility Name
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
City
Suleymanpasa
State/Province
Tekirdas
ZIP/Postal Code
59100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324333676
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 505 502 50 50
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324089525
Facility Name
Ege Universitesi Hastanesi ( Site 4902)
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325566128

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1026-008&kw=1026-008
Description
Plain Language Summary

Learn more about this 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)

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