Trial Title:
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
NCT ID:
NCT05949684
Condition:
Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Anemia
Myelodysplastic Syndromes
Syndrome
Epoetin Alfa
Luspatercept
Conditions: Keywords:
Luspatercept
BMS-986346
ACE-536
Myelodysplastic Syndrome
Epoetin alfa
Erythropoietin stimulating agent (ESA)
Myelodysplastic Syndromes (MDS)
Anaemia
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:
Biological
Intervention name:
Luspatercept
Description:
Specified dose on specified days
Arm group label:
Luspatercept
Other name:
BMS-986346
Other name:
ACE-536
Other name:
Reblozyl®
Intervention type:
Biological
Intervention name:
Epoetin Alfa
Description:
Specified dose on specified days
Arm group label:
Epoetin Alfa
Other name:
Epogen®
Other name:
PROCRIT®
Other name:
BINOCRIT
Summary:
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin
alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk
MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Participant has documented diagnosis of MDS according to World Health Organization
(WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk
disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow
aspirate and:.
i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
- Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
- Participant is erythropoiesis-stimulating agent naive. Participants may be
randomized at the investigator's discretion if the participant received no more than
2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with
the last dose at least 8 weeks prior to randomization.
- Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500
U/L.
- Participant has symptoms of anemia:.
i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S
item of fatigue, weakness, shortness of breath, or dizziness performed during the
screening period.
- Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL.
The baseline Hb will be calculated using the mean of the two lowest available Hb
measurements within 16 weeks prior to randomization and must include at least one
central lab Hb reading done within the screening period (no more than 35 days before
randomization). The two Hb measurements must have been performed at least seven days
apart. Hb levels less than 21 days following RBC transfusion should not be used.
Split samples for local assessments are not required.
Exclusion Criteria
- Participant with secondary MDS (that is, MDS that is known to have arisen as the
result of chemical injury or treatment with chemotherapy and/or radiation for other
diseases).
- Participant with known history of diagnosis of AML.
- Participant with history of cerebrovascular accident (including ischemic, embolic,
and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous
thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial
thrombosis, or other venous thrombosis within 6 months prior to randomization.
- Participant with a history of pure red cell aplasia and/or antibody against
erythropoietin.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Community Cancer Institute
Address:
City:
Clovis
Zip:
93611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Haifaa Abdulhaq, Site 0070
Phone:
559-618-6208
Facility:
Name:
John Muir Medical Center - Concord Campus
Address:
City:
Concord
Zip:
94520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gigi Chen, Site 0183
Phone:
925-674-2580
Facility:
Name:
Compassionate Cancer Care Medical Group
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Haresh Jhangiani, Site 0179
Phone:
951-371-2411
Facility:
Name:
Local Institution - 0095
Address:
City:
Fresno
Zip:
93703
Country:
United States
Status:
Withdrawn
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vu Quang Phan, Site 0211
Phone:
562-735-0602
Facility:
Name:
Local Institution - 0258
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0258
Facility:
Name:
Local Institution - 0247
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0247
Facility:
Name:
Ventura County Hematology Oncology Specialists
Address:
City:
Oxnard
Zip:
93030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lynn Kong, Site 0209
Phone:
000-000-0000
Facility:
Name:
Local Institution - 0098
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Withdrawn
Facility:
Name:
Hartford Hospital (HH)
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Devendra KC, Site 0227
Phone:
860-972-5361
Facility:
Name:
Yale-New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amer Zeidan, Site 0173
Phone:
203-737-7078
Facility:
Name:
Halifax Health Medical Center
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ruby Anne Deveras, Site 0231
Phone:
386-254-4212
Facility:
Name:
Local Institution - 0230
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Status:
Withdrawn
Facility:
Name:
Florida Cancer Specialists - South
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Syed Zafar, Site 0202
Phone:
239-274-9930
Facility:
Name:
Baptist MD Anderson Cancer Center
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maxim Norkin, Site 0180
Phone:
248-756-4524
Facility:
Name:
D&H Cancer Research Center LLC
Address:
City:
Margate
Zip:
33063
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Kahn, Site 0224
Phone:
954-773-9890
Facility:
Name:
BRCR Global
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason Tache, Site 0163
Phone:
516-447-0614
Facility:
Name:
Florida Cancer Specialists - North
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gustavo Fonseca, Site 0201
Phone:
000-000-0000
Facility:
Name:
Advanced Research
Address:
City:
Tamarac
Zip:
33321
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sumit Sawhney, Site 0238
Phone:
954-302-3120
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
rami komrokji, Site 0106
Phone:
513-504-9712
Facility:
Name:
Local Institution - 0240
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0240
Facility:
Name:
Local Institution - 0272
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0272
Facility:
Name:
Orchard Healthcare Research Inc.
Address:
City:
Skokie
Zip:
60077
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ira Oliff, Site 0184
Phone:
224-534-7580
Facility:
Name:
Local Institution - 0270
Address:
City:
Dyer
Zip:
46311
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0270
Facility:
Name:
Local Institution - 0232
Address:
City:
Pikeville
Zip:
41501
Country:
United States
Status:
Withdrawn
Facility:
Name:
Our Lady of the Lake RMC
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marshall Stagg, Site 0191
Phone:
225-765-3344
Facility:
Name:
Pontchartrain Cancer Center
Address:
City:
Covington
Zip:
70433
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Oubre, Site 0044
Phone:
985-875-1202
Facility:
Name:
Local Institution - 0097
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Withdrawn
Facility:
Name:
American Oncology Partners of Maryland, PA
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ralph Boccia, Site 0007
Phone:
301-571-2016
Facility:
Name:
Metro-Minnesota Community Clinical Oncology
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yan Ji, Site 0222
Phone:
952-993-3252
Facility:
Name:
Hattiesburg Clinic Hematology/Oncology
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Hrom, Site 0128
Phone:
601-261-1700
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Koprivnikar, Site 0212
Phone:
551-996-3925
Facility:
Name:
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Uma Borate, Site 0206
Phone:
503-418-2294
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wahid Hanna, Site 0174
Phone:
865-544-9171
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guillermo Garcia-Manero, Site 0228
Phone:
713-745-3428
Facility:
Name:
Local Institution - 0236
Address:
City:
Richmond
Zip:
23219
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0236
Facility:
Name:
Blue Ridge Cancer Care
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Gillespie-Twardy, Site 0229
Phone:
540-982-0237
Facility:
Name:
Kadlec Clinic Hematology and Oncology
Address:
City:
Kennewick
Zip:
99336
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rangaswamy Chintapatla, Site 0203
Phone:
509-783-4637
Facility:
Name:
Local Institution - 0213
Address:
City:
Seattle
Zip:
98133
Country:
United States
Status:
Withdrawn
Facility:
Name:
Centro Mdico "Barrio Parque"
Address:
City:
Buenos Aires
Zip:
C1425DND
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Claudio Iastrebner, Site 0010
Phone:
+54-911-69816300
Facility:
Name:
Local Institution - 0012
Address:
City:
Buenos Aires
Zip:
CP1280AEB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Site 0012
Facility:
Name:
Local Institution - 0009
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
C1426ANZ
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Site 0009
Facility:
Name:
Blacktown Hospital
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kenny Tang, Site 0071
Phone:
0286708421
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Stephen Larsen, Site 0113
Phone:
+6195158031
Facility:
Name:
Coffs Harbour Health Campus
Address:
City:
Coffs Harbour
Zip:
2450
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kyle Crassini, Site 0254
Phone:
0439119527
Facility:
Name:
Pindara Private Hospital
Address:
City:
Gold Coast
Zip:
4217
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Hanlon Sia, Site 0246
Phone:
+61755067812
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jake Shortt, Site 0054
Phone:
+61412633726
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Chun Fong, Site 0052
Phone:
61394966731
Facility:
Name:
Hospital Universitario Walter Cantidio
Address:
City:
Fortaleza
Zip:
60430-270
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Silvia Maria Magalhaes, Site 0059
Phone:
85999818108
Facility:
Name:
Hospital São Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Mariza Schaan, Site 0101
Phone:
55 5133203319
Facility:
Name:
HEMORIO
Address:
City:
Rio de Janeiro
Zip:
20211-030
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Viviani Pessoa, Site 0056
Phone:
21-981698808
Facility:
Name:
Hospital das Clinicas FMUSP
Address:
City:
São Paulo
Zip:
05403-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Elvira Velloso, Site 0003
Phone:
+551145737631
Facility:
Name:
Arthur J.E. Child Comprehensive Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Michelle Geddes, Site 0049
Phone:
4039448047
Facility:
Name:
St. Paul's Hospital
Address:
City:
Vancouver
Zip:
V6Z 1Y6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Heather Leitch, Site 0112
Phone:
0000000000
Facility:
Name:
Victoria Hospital & Children's Hospital - London Health Sciences Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
lalit Saini, Site 0050
Phone:
519-685-8500x56072
Facility:
Name:
Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Rena Buckstein, Site 0017
Phone:
4163992979
Facility:
Name:
Local Institution - 0280
Address:
City:
Santiago
Zip:
7500587
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0280
Facility:
Name:
Local Institution - 0278
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0278
Facility:
Name:
Local Institution - 0276
Address:
City:
Santiago
Zip:
7580206
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0276
Facility:
Name:
Local Institution - 0277
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0277
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230071
Country:
China
Status:
Recruiting
Contact:
Last name:
Baolin Tang, Site 0109
Phone:
13856901277
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
hongxia shi, Site 0217
Phone:
13661049635
Facility:
Name:
Beijing Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Han, Site 0030
Phone:
8613601059938
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Contact:
Last name:
li wang, Site 0223
Phone:
18623015252
Facility:
Name:
Local Institution - 0096
Address:
City:
Fuzhou Fujian
Zip:
350001
Country:
China
Status:
Withdrawn
Facility:
Name:
The First Affiliated hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
bing xu, Site 0220
Phone:
18750918842
Facility:
Name:
Local Institution - 0031
Address:
City:
Guangzhou
Zip:
450008
Country:
China
Status:
Withdrawn
Facility:
Name:
Local Institution - 0266
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site 0266
Facility:
Name:
The First Hospital of Harbin
Address:
City:
Harbin
Zip:
150010
Country:
China
Status:
Recruiting
Contact:
Last name:
Tiejun Gong, Site 0038
Phone:
13836027737
Facility:
Name:
People's Hospital of Henan Province
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
zunmin zhu, Site 0194
Phone:
13603712008
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430058
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Zhang, Site 0108
Phone:
15871818568
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajing Xu, Site 0089
Phone:
13875804518
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangsheng He, Site 0032
Phone:
8615312052798
Facility:
Name:
Local Institution - 0083
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site 0083
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li, Site 0079
Phone:
13970038386
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
sujun gao, Site 0043
Phone:
+86 15843073208
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Yan, Site 0048
Phone:
13889128302
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266003
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wang, Site 0111
Phone:
18661807392
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunkang Chang, Site 0218
Phone:
8613764643870
Facility:
Name:
Shaanxi provincial people's hospital
Address:
City:
Xi'an
Zip:
710068
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi WANG, Site 0216
Phone:
13571936193
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Wu, Site 0075
Phone:
18980601973
Facility:
Name:
Institute of hematology&blood disease hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
zhijian xiao, Site 0103
Phone:
+86 13821085716
Facility:
Name:
The first Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyan Tong, Site 0029
Phone:
13958122357
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
32500
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng Luo, Site 0033
Phone:
+8613957747543
Facility:
Name:
Hospital Pablo Tobon Uribe
Address:
City:
Medellin
Zip:
05034
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Kenny Galvez, Site 0147
Phone:
5731489056030000
Facility:
Name:
Sociedad De Oncologia Y Hematologia Del Cesar
Address:
City:
Valledupar
Zip:
200001
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Carmen Rosales, Site 0152
Phone:
3112620177
Facility:
Name:
Local Institution - 0267
Address:
City:
Piedecuesta
Zip:
681017
Country:
Colombia
Status:
Not yet recruiting
Contact:
Last name:
Site 0267
Facility:
Name:
Local Institution - 0149
Address:
City:
Montería
Zip:
230002
Country:
Colombia
Status:
Not yet recruiting
Contact:
Last name:
Site 0149
Facility:
Name:
Fakultní nemocnice Brno Bohunice
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiri Mayer, Site 0080
Phone:
420532233642
Facility:
Name:
Fakultni nemocnice Ostrava
Address:
City:
Ostrava
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Zdenek Koristek, Site 0092
Phone:
+420597374566
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Anna JONASOVA, Site 0090
Phone:
+420224966209
Facility:
Name:
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Address:
City:
Nice
Zip:
06202
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas Cluzeau, Site 0011
Phone:
33492039268
Facility:
Name:
CHU Bordeaux Haut-Leveque
Address:
City:
Pessac
Zip:
33600
Country:
France
Status:
Recruiting
Contact:
Last name:
Sophie Dimicoli-Salazar, Site 0016
Phone:
33557656511
Facility:
Name:
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Address:
City:
Tours
Zip:
37032
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuel Gyan, Site 0019
Phone:
+33247473712
Facility:
Name:
Chu Grenoble Alpes
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Contact:
Last name:
Mathieu Meunier, Site 0116
Phone:
33476765755
Facility:
Name:
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Address:
City:
Vandoeuvre lès Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
Maud D'Aveni, Site 0165
Phone:
0609481716
Facility:
Name:
Local Institution - 0269
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0269
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Christophe WILLEKENS, Site 0248
Phone:
0142114211
Facility:
Name:
Hôpital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre FENAUX, Site 0015
Phone:
+33171207022
Facility:
Name:
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Recruiting
Contact:
Last name:
Thibault Comont, Site 0140
Phone:
0033531156266
Facility:
Name:
Local Institution - 0261
Address:
City:
Erding
Zip:
85435
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site 0261
Facility:
Name:
Local Institution - 0250
Address:
City:
Kempten
Zip:
87439
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Local Institution - 0259
Address:
City:
Münster
Zip:
48153
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site 0259
Facility:
Name:
InVO Institut für Versorgungsforschung in der Onkologie
Address:
City:
Koblenz
Zip:
56068
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Rudolf Weide, Site 0168
Phone:
4926192156930
Facility:
Name:
Universitätsklinikum Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dominic Brauer, Site 0171
Phone:
493419713859
Facility:
Name:
Universitätsklinikum Jena
Address:
City:
Jena
Zip:
07747
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Carl Crodel, Site 0251
Phone:
4936419324236
Facility:
Name:
Praxis fur Hamatologie und Onkologie
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stephan Fuhrmann, Site 0169
Phone:
+49(0)15254777515
Facility:
Name:
Local Institution - 0028
Address:
City:
Berlin
Zip:
14195
Country:
Germany
Status:
Completed
Facility:
Name:
Universitaetsklinikum Duesseldorf
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Norbert Gattermann, Site 0207
Phone:
0211-81 16500
Facility:
Name:
Local Institution - 0255
Address:
City:
Lübeck
Zip:
23562
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site 0255
Facility:
Name:
Kliniken Ostalb, Stauferklinikum
Address:
City:
Mutlangen
Zip:
73557
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Holger Hebart, Site 0167
Phone:
4971717011302
Facility:
Name:
Gemeinschaftspraxis Dr. med. Björn Schöttker & Dominik Pretscher
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Bjoern Schoettker, Site 0166
Phone:
0931322670
Facility:
Name:
Local Institution - 0242
Address:
City:
Patras
Zip:
26504
Country:
Greece
Status:
Withdrawn
Facility:
Name:
University Hospital of Patras
Address:
City:
Patras
Zip:
26504
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Alexandros Spyridonidis, Site 0132
Phone:
306977448977
Facility:
Name:
General Hospital of Athens "G. Gennimatas"
Address:
City:
Athens
Zip:
115 27
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Eurydiki Michalis, Site 0084
Phone:
+306944452898
Facility:
Name:
Local Institution - 0245
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 0245
Facility:
Name:
Attikon General University Hospital
Address:
City:
Chaidari
Zip:
12462
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Vasiliki Pappa, Site 0131
Phone:
00306937255084
Facility:
Name:
University Hospital of Alexandroupolis
Address:
City:
Alexandroupolis
Zip:
08100
Country:
Greece
Status:
Recruiting
Contact:
Last name:
IOANNIS KOTSIANIDIS, Site 0082
Phone:
+302551353739
Facility:
Name:
Local Institution - 0034
Address:
City:
Hksar
Zip:
0
Country:
Hong Kong
Status:
Withdrawn
Facility:
Name:
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
Address:
City:
Eger
Zip:
3300
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Balazs Tajti, Site 0024
Phone:
0036704223242
Facility:
Name:
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Address:
City:
Nyiregyhaza
Zip:
4400
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Laszlo Rejto, Site 0021
Phone:
42599700
Facility:
Name:
Semmelweis Egyetem
Address:
City:
Budapest
Zip:
1088
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
ZSOLT GYORGY Nagy, Site 0026
Phone:
36208258660
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Contact:
Last name:
Tulika Seth, Site 0193
Facility:
Name:
Local Institution - 0235
Address:
City:
New Delhi
Zip:
110085
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Site 0235
Facility:
Name:
Hemato Oncology Clinic
Address:
City:
Ahmedabad
Zip:
380009
Country:
India
Status:
Recruiting
Contact:
Last name:
Sandip A. Shah, Site 0243
Phone:
9824041170
Facility:
Name:
Local Institution - 0273
Address:
City:
Ahmedabad
Zip:
382428
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Site 0273
Facility:
Name:
Local Institution - 0177
Address:
City:
Bengaluru
Zip:
560027
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Site 0177
Facility:
Name:
Institute of Medical Sciences and Sum Hospital
Address:
City:
Bhubaneswar
Zip:
751003
Country:
India
Status:
Recruiting
Contact:
Last name:
Priyanka Samal, Site 0178
Phone:
8902621993
Facility:
Name:
Local Institution - 0185
Address:
City:
Hyderabad
Zip:
500034
Country:
India
Status:
Withdrawn
Facility:
Name:
Local Institution - 0186
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Withdrawn
Facility:
Name:
Local Institution - 0256
Address:
City:
Rome
Zip:
00133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0256
Facility:
Name:
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Address:
City:
Milano
Zip:
20122
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Bruno Fattizzo, Site 0137
Phone:
0255033477
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milan
Zip:
20162
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marta Riva, Site 0134
Phone:
0264442668
Facility:
Name:
Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Matteo Giovanni Della Porta, Site 0136
Phone:
0282247668
Facility:
Name:
Azienda Ospedaliera Ordine Mauriziano di Torino
Address:
City:
Torino
Zip:
10128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniela Cilloni, Site 0085
Phone:
+390115082224
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
VALERIA SANTINI, Site 0138
Phone:
0557947296
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefania Paolini, Site 0135
Phone:
+393392231941
Facility:
Name:
Grande Ospedale Metropolitano - Presidio Morelli
Address:
City:
Reggio Calabria
Zip:
89133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Caterina Alati, Site 0076
Phone:
390965397879
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luana Fianchi, Site 0244
Phone:
00390630154180
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Bernardelli, Site 0133
Phone:
3272052368
Facility:
Name:
Local Institution - 0123
Address:
City:
Kitakyushu-shi
Zip:
8068501
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0117
Address:
City:
Sapporo
Zip:
064-0804
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0126
Address:
City:
Amagasaki
Zip:
660-8550
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0120
Address:
City:
Sagamihara
Zip:
252-0375
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0118
Address:
City:
Sendai-shi
Zip:
980-8574
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0125
Address:
City:
Osaka-sayama
Zip:
589-8511
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0121
Address:
City:
Shimotsuga
Zip:
321-0293
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0124
Address:
City:
Nagasaki
Zip:
852-8104
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0122
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Local Institution - 0119
Address:
City:
Tokyo
Zip:
141-8625
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Hematológica Alta Especialidad SC, consultorio 830
Address:
City:
Huixquilucan
Zip:
52787
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Roberto Ovilla Martinez, Site 0069
Phone:
5215521291399
Facility:
Name:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
María Demichelis, Site 0142
Phone:
525555018036
Facility:
Name:
Local Institution - 0156
Address:
City:
Oaxaca
Zip:
68020
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0156
Facility:
Name:
Unidad Médica Onco-hematológica
Address:
City:
Puebla
Zip:
72424
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Xochiquetzatl Jimenez Lopez, Site 0150
Phone:
522222379880
Facility:
Name:
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Address:
City:
Wałbrzych
Zip:
58-309
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Aleksandra Butrym, Site 0130
Phone:
+48502657840
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdańsk
Zip:
80-952
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Ewa Zarzycka, Site 0060
Phone:
+48609803080
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Sebastian Grosicki, Site 0061
Phone:
+48600388282
Facility:
Name:
MTZ Clinical Research powered by Pratia
Address:
City:
Warsaw
Zip:
02-172
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Krzysztof Madry, Site 0062
Phone:
485725959
Facility:
Name:
Auxilio Mutuo Cancer Center
Address:
City:
San Juan
Zip:
00917
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Adelba Torres Lopez, Site 0219
Phone:
7877582000
Facility:
Name:
Local Institution - 0237
Address:
City:
San Juan
Zip:
00917
Country:
Puerto Rico
Status:
Withdrawn
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
David Ferreiras, Site 0198
Phone:
34934893000Ext6417
Facility:
Name:
Institut Català d'Oncologia - L'Hospitalet
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Montserrat Arnan Sangerman, Site 0197
Phone:
34932607750
Facility:
Name:
Hospital Clinico de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria del Tormo Diaz, Site 0196
Phone:
+34961973838
Facility:
Name:
Hospital Universitario Virgen Nieves
Address:
City:
Granada
Zip:
18012
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Francisca Hernandez Mohedo, Site 0199
Phone:
696069226
Facility:
Name:
Hospital La Princesa
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
VALLE GOMEZ GARCIA DE SORIA, Site 0252
Phone:
34915202241
Facility:
Name:
Local Institution - 0271
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 0271
Facility:
Name:
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Diez, Site 0200
Phone:
34699508223
Facility:
Name:
Local Institution - 0274
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 0274
Start date:
October 24, 2023
Completion date:
March 11, 2030
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949684
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05949684.html
