Trial Title:
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
NCT ID:
NCT06136559
Condition:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Acalabrutinib
Ibrutinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nemtabrutinib
Description:
Administered orally
Arm group label:
Nemtabrutinib
Other name:
MK-1026
Other name:
ARQ 531
Intervention type:
Drug
Intervention name:
Ibrutinib
Description:
Administered orally
Arm group label:
Ibrutinib/Acalabrutinib
Intervention type:
Drug
Intervention name:
Acalabrutinib
Description:
Administered orally
Arm group label:
Ibrutinib/Acalabrutinib
Summary:
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice
of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia
(CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The
primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or
acalabrutinib with respect to objective response rate (ORR) per International Workshop on
Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review
(BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to
progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need
to initiate therapy.
- Has at least 1 marker of disease burden.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within
7 days before randomization.
- Has the ability to swallow and retain oral medication.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if
they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks
and have undetectable HBV deoxyribonucleic acid (DNA) viral load before
randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
ribonucleic acid (RNA) viral load is undetectable at screening.
- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility
criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- Has diagnosis of Richter Transformation or active central nervous system (CNS)
involvement by CLL/SLL.
- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection
in the past 12 months before screening.
- Has clinically significant cardiovascular disease.
- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or
acalabrutinib, or any of the excipients.
- Has history of severe bleeding disorder.
- Has history of second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.
- Has received any systemic anticancer therapy for CLL/SLL.
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow
therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A
strong inhibitors.
- Received prior radiotherapy within 2 weeks of start of study intervention, or
radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks before study intervention administration.
- Has active infection requiring systemic therapy.
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USA Mitchell Cancer Institute ( Site 0014)
Address:
City:
Mobile
Zip:
36604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
251-665-8000
Facility:
Name:
Alta Bates Summit Medical Center ( Site 0004)
Address:
City:
Berkeley
Zip:
94704
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
510-204-1591
Facility:
Name:
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
989-488-9506
Facility:
Name:
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017)
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
319-356-4200
Facility:
Name:
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
616-486-6180
Facility:
Name:
Summit Medical Group Cancer Center ( Site 0007)
Address:
City:
Florham Park
Zip:
07932
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
973-538-5210
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
201-341-5859
Facility:
Name:
Cancer Care Associates Of York ( Site 0005)
Address:
City:
York
Zip:
17403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
717-741-8303
Facility:
Name:
Inova Schar Cancer Institute ( Site 0015)
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
864-609-7211
Facility:
Name:
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Address:
City:
Spokane
Zip:
99208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
509-462-2273
Facility:
Name:
University Hospital and UW Health Clinics ( Site 0006)
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
608-262-9317
Facility:
Name:
Royal North Shore Hospital ( Site 2806)
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+61403346203
Facility:
Name:
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Address:
City:
Mechelen
Zip:
2800
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
015891011
Facility:
Name:
UZ Leuven-Hematology ( Site 0200)
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3216346880
Facility:
Name:
Hospital 9 De Julho ( Site 2206)
Address:
City:
São Paulo
Zip:
01409-001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5511989395815
Facility:
Name:
Instituto Nacional de Câncer - INCA ( Site 2201)
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+552199616963
Facility:
Name:
Hospital Paulistano-Americas Oncologia ( Site 2202)
Address:
City:
Sao Paulo
Zip:
01321-001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5511992926463
Facility:
Name:
BC Cancer Victoria ( Site 0109)
Address:
City:
Victoria
Zip:
V8R 6V5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
250-519-5500
Facility:
Name:
William Osler Health System ( Site 0103)
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905-494-2120
Facility:
Name:
The Ottawa Hospital - General Campus ( Site 0102)
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
613-737-8899 ext. 79509
Facility:
Name:
McGill University Health Centre ( Site 0106)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
514-934-1934
Facility:
Name:
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski (
Address:
City:
Rimouski
Zip:
G5L 5T1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
418-724-3000
Facility:
Name:
FALP-UIDO ( Site 2300)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56984290128
Facility:
Name:
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Address:
City:
Santiago
Zip:
7650568
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56992794676
Facility:
Name:
Bradfordhill-Clinical Area ( Site 2310)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56998467083
Facility:
Name:
Anhui Provincial Cancer Hospital ( Site 2001)
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618900518383
Facility:
Name:
Peking University First Hospital ( Site 2022)
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13501385729
Facility:
Name:
Peking University Third Hospital-Hematology ( Site 2011)
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 15611908428
Facility:
Name:
Chongqing University Cancer Hospital ( Site 2041)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13608320221
Facility:
Name:
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13802426709
Facility:
Name:
Sun Yat-sen University Cancer Center ( Site 2028)
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613719189172
Facility:
Name:
Liuzhou People's Hospital ( Site 2029)
Address:
City:
Liuzhou
Zip:
545006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13877299966
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
Address:
City:
Nanning
Zip:
530200
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0771-5313603
Facility:
Name:
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
Address:
City:
Guiyang
Zip:
550004
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0851-86740793
Facility:
Name:
Hainan General Hospital ( Site 2018)
Address:
City:
Haikou
Zip:
570311
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13976595976
Facility:
Name:
Henan Cancer Hospital-hematology department ( Site 2025)
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13674902391
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 2016)
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13871454649
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015)
Address:
City:
Wuhan
Zip:
430010
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18627091655
Facility:
Name:
The Second Xiangya Hospital of Central South University ( Site 2010)
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13975806137
Facility:
Name:
Hunan Cancer Hospital ( Site 2020)
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 19918803330
Facility:
Name:
Jiangsu Province Hospital ( Site 2000)
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13951877733
Facility:
Name:
The First Affliated Hospital of Suzhou University ( Site 2027)
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13962154846
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
Address:
City:
Xuzhou
Zip:
221006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0516-85802369
Facility:
Name:
The First Affiliated Hospital of Nanchang University ( Site 2023)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13970038386
Facility:
Name:
Jiangxi Provincial Cancer Hospital ( Site 2009)
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86 13755669955
Facility:
Name:
The First Hospital of Jilin University-Hematology ( Site 2030)
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 15843073208
Facility:
Name:
Shaanxi provincial people's hospital ( Site 2012)
Address:
City:
Xian
Zip:
710068
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13571936193
Facility:
Name:
Shandong Cancer Hospital ( Site 2003)
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13642138692
Facility:
Name:
Shanxi Cancer Hospital ( Site 2033)
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613835158122
Facility:
Name:
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86+18980601027
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18622221227
Facility:
Name:
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
Address:
City:
Tianjin
Zip:
301617
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15900265414
Facility:
Name:
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
Address:
City:
Urumqi
Zip:
830000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18160631686
Facility:
Name:
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13505716779
Facility:
Name:
Zhejiang Cancer Hospital ( Site 2017)
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13857182590
Facility:
Name:
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Address:
City:
Valledupar
Zip:
200001
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3112620177
Facility:
Name:
Oncomédica S.A.S ( Site 2401)
Address:
City:
Montería
Zip:
230002
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
7848997
Facility:
Name:
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
Address:
City:
Cali
Zip:
760032
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
23319090
Facility:
Name:
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+420495832785
Facility:
Name:
Fakultni nemocnice Olomouc ( Site 0303)
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+420588445316
Facility:
Name:
Aalborg Universitetshospital, Syd ( Site 0403)
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
004561276282
Facility:
Name:
Roskilde Sygehus-Department of Hematology ( Site 0402)
Address:
City:
Roskilde
Zip:
4000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+45 47324809
Facility:
Name:
Odense Universitetshospital-Department of Hematology ( Site 0401)
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
004524634689
Facility:
Name:
VK&K Studien GbR ( Site 0607)
Address:
City:
Landshut
Zip:
84036
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0871 97403429
Facility:
Name:
Kliniken Maria Hilf ( Site 0603)
Address:
City:
Mönchengladbach
Zip:
41063
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4921618922201
Facility:
Name:
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
Address:
City:
Koblenz
Zip:
56068
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
49261921569323
Facility:
Name:
Universitätsklinikum Halle ( Site 0604)
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
493455572904
Facility:
Name:
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
Address:
City:
Berlin
Zip:
10707
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
49308877425740
Facility:
Name:
University Hospital of Alexandroupolis ( Site 0701)
Address:
City:
Alexandroupolis
Zip:
681 00
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+302551353739
Facility:
Name:
Evangelismos General Hospital of Athens ( Site 0700)
Address:
City:
Athens
Zip:
106 76
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00306977318242
Facility:
Name:
University Hospital of Ioannina ( Site 0702)
Address:
City:
Ioannina
Zip:
455 00
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
2651099656
Facility:
Name:
Queen Mary Hospital ( Site 3300)
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
22551654
Facility:
Name:
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97247772541
Facility:
Name:
Bnai Zion Medical Center ( Site 1505)
Address:
City:
Haifa
Zip:
3339419
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00972506268114
Facility:
Name:
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97226778180
Facility:
Name:
Rabin Medical Center ( Site 1504)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972-54-3040555
Facility:
Name:
Sheba Medical Center-Hemato Oncology ( Site 1501)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972526669155
Facility:
Name:
Yitzhak Shamir Medical Center. ( Site 1506)
Address:
City:
Zerifin
Zip:
70300
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97289542443
Facility:
Name:
Nagoya University Hospital ( Site 1907)
Address:
City:
Nagoya
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-52-741-2111
Facility:
Name:
Gunma University Hospital ( Site 1903)
Address:
City:
Maebashi
Zip:
371-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81 272207111
Facility:
Name:
Hokkaido University Hospital ( Site 1900)
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-11-716-1161
Facility:
Name:
Kobe City Medical Center General Hospital ( Site 1910)
Address:
City:
Kobe
Zip:
650-0047
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-78-302-4321
Facility:
Name:
Tohoku University Hospital ( Site 1901)
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81 227177000
Facility:
Name:
Kindai University Hospital- Osakasayama Campus ( Site 1909)
Address:
City:
Osaka-sayama
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-72-366-0221
Facility:
Name:
Shimane University Hospital ( Site 1911)
Address:
City:
Izumo
Zip:
693-8501
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-853-23-2111
Facility:
Name:
Japanese Foundation for Cancer Research ( Site 1906)
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81335200111
Facility:
Name:
Chiba cancer center ( Site 1905)
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-43-264-5431
Facility:
Name:
Kyushu University Hospital ( Site 1914)
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-92-641-1151
Facility:
Name:
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
Address:
City:
Hiroshima
Zip:
730-0052
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81 822413111
Facility:
Name:
Okayama University Hospital ( Site 1912)
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-86-223-7151
Facility:
Name:
Osaka Red Cross Hospital ( Site 1908)
Address:
City:
Osaka
Zip:
543-8555
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-6-6774-5111
Facility:
Name:
Yamagata University Hospital ( Site 1902)
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81236285840
Facility:
Name:
Hospital Pulau Pinang ( Site 1602)
Address:
City:
George Town
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0166436587
Facility:
Name:
Waikato Hospital-Haematology ( Site 3202)
Address:
City:
Hamilton
Zip:
3240
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+6421408513
Facility:
Name:
North Shore Hospital-Department of Haematology ( Site 3200)
Address:
City:
Auckland
Zip:
0622
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
64948689207108
Facility:
Name:
Aotearoa Clinical Trials ( Site 3201)
Address:
City:
Auckland
Zip:
2025
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6492760044ext8928
Facility:
Name:
Akershus Universitetssykehus ( Site 0902)
Address:
City:
Lørenskog
Zip:
1474
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+47 97595035
Facility:
Name:
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
Address:
City:
Oslo
Zip:
0372
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
004748269428
Facility:
Name:
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Address:
City:
Arequipa
Zip:
054
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
980728089
Facility:
Name:
Clínica Anglo Americana ( Site 2701)
Address:
City:
Lima
Zip:
15073
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5116168900
Facility:
Name:
Pratia MCM Krakow ( Site 1007)
Address:
City:
Krakow
Zip:
30-727
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48 602338290
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48225462223
Facility:
Name:
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48608466730
Facility:
Name:
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
Address:
City:
Gliwice
Zip:
44-101
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48322788523
Facility:
Name:
Pratia Onkologia Katowice ( Site 1009)
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48600388282
Facility:
Name:
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit
Address:
City:
Olsztyn
Zip:
10-228
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
895398133
Facility:
Name:
Champalimaud Foundation ( Site 3102)
Address:
City:
Lisbon
Zip:
1400-038
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
351210480048
Facility:
Name:
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
Address:
City:
Lisbon
Zip:
1649-035
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+351217805000
Facility:
Name:
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
Address:
City:
Lisboa
Zip:
1449-005
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+351210431730
Facility:
Name:
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
351225084000
Facility:
Name:
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
Address:
City:
Centurion
Zip:
0181
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+27 12 993 2555
Facility:
Name:
Wits Clinical Research ( Site 1102)
Address:
City:
Johannesburg
Zip:
1864
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+27119836501
Facility:
Name:
Groote Schuur Hospital-Clinical Haematology ( Site 1100)
Address:
City:
Cape Town
Zip:
7925
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0727689024
Facility:
Name:
Haemalife ( Site 1105)
Address:
City:
Kuilsriver
Zip:
7580
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+27219006277
Facility:
Name:
Constantiaberg Haematology ( Site 1106)
Address:
City:
Plumstead
Zip:
7800
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0217616600
Facility:
Name:
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
Address:
City:
L'Hospitalet Del Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34932607750
Facility:
Name:
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34619085109
Facility:
Name:
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34 680961621
Facility:
Name:
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34 914521900
Facility:
Name:
hospital universitario de canarias ( Site 1205)
Address:
City:
La Laguna
Zip:
38320
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34 922678207
Facility:
Name:
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34934893806
Facility:
Name:
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3492329110055629
Facility:
Name:
Karolinska Universitetssjukhuset Solna ( Site 1302)
Address:
City:
Stockholm
Zip:
171 64
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+46707574141
Facility:
Name:
Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
Address:
City:
Muang
Zip:
50200
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+66-826949794
Facility:
Name:
Chulalongkorn University ( Site 1802)
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
66022564000 ext 80251
Facility:
Name:
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+66840114290
Facility:
Name:
Naresuan University Hospital ( Site 1804)
Address:
City:
Muang
Zip:
65000
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+6655965043
Facility:
Name:
Songklanagarind hospital ( Site 1803)
Address:
City:
HatYai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+66815990379
Facility:
Name:
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
05055025050
Facility:
Name:
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905336512142
Facility:
Name:
Trakya University-Balkan Onkoloji Hastanesi ( Site 1403)
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905335544797
Facility:
Name:
Southmead Hospital ( Site 3010)
Address:
City:
Bristol
Zip:
BS10 5NB
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0117 414 8399
Facility:
Name:
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
07917832097
Facility:
Name:
The Churchill Hospital ( Site 3007)
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
441865235886
Facility:
Name:
GenesisCare - Cambridge ( Site 3001)
Address:
City:
Newmarket
Zip:
CB8 7XN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
01223216747
Facility:
Name:
GenesisCare - Windsor ( Site 3002)
Address:
City:
Windsor
Zip:
SL4 3HD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
447989474250
Facility:
Name:
Barnet Hospital ( Site 3005)
Address:
City:
Barnet
Zip:
EN5 3DJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
020 7433 0065 ext 36377
Facility:
Name:
St James's University Hospital ( Site 3004)
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00447901740934
Start date:
December 13, 2023
Completion date:
September 30, 2032
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136559
http://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1026-011&kw=1026-011
