Back to resultsA Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Primary Purpose
Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral Azacitidine
Placebo for Oral Azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Anemia, Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification 17 of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).
MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria:
- Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
- Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
- Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
- Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- University of Miami Hospital and Clinics, Sylvester Cancer Center
- Advanced Research
- Moffitt Cancer Center
- Henry Ford Hospital
- Rutgers Cancer Institute of New Jersey
- Hematology-Oncology Associates of Central New York, PCRecruiting
- Memorial Sloan Kettering Cancer Center
- Novant Health Presbyterian Medical Center
- Oregon Health and Science University
- AHN West Penn HospitalRecruiting
- Charleston Oncology, P.A.
- Houston Methodist Hospital
- University of Texas MD Anderson Cancer CenterRecruiting
- Huntsman Cancer Institute
- Inova Schar Cancer InstituteRecruiting
- Local Institution - 0070Recruiting
- Local Institution - 0039Recruiting
- Local Institution - 0021
- Local Institution - 0016Recruiting
- Local Institution - 0022Recruiting
- Local Institution - 0050Recruiting
- Local Institution - 0144
- Local Institution - 0145
- Local Institution - 0146
- Local Institution - 0006Recruiting
- Local Institution - 0069
- Local Institution - 0018Recruiting
- Local Institution - 0004Recruiting
- Local Institution - 0003Recruiting
- Local Institution - 0034
- Local Institution - 0029
- Local Institution - 0074
- Local Institution - 0091
- Local Institution - 0008Recruiting
- Local Institution - 0015Recruiting
- Local Institution - 0090Recruiting
- Local Institution - 0171
- Local Institution - 0167
- Local Institution - 0156
- Local Institution - 0157
- Local Institution - 0168
- Local Institution - 0162
- Local Institution - 0163
- Local Institution - 0179
- Local Institution - 0166
- Local Institution - 0160
- Local Institution - 0169
- Local Institution - 0164
- Local Institution - 0165
- Local Institution - 0141
- Local Institution - 0161
- Local Institution - 0170
- Local Institution - 0009
- Local Institution - 0060Recruiting
- Local Institution - 0045
- Local Institution - 0115Recruiting
- Local Institution - 0116
- Local Institution - 0114
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
- CHU Bordeaux Haut-LevequeRecruiting
- Centre Hospitalier Régional Universitaire de Tours - Hôpital BretonneauRecruiting
- Centre Hospitalier Universitaire d'AngersRecruiting
- Hopital Claude Huriez - CHU de LilleRecruiting
- Gustave RoussyRecruiting
- Hôpital Saint-LouisRecruiting
- Local Institution - 0059
- Local Institution - 0081Recruiting
- Local Institution - 0128Recruiting
- Local Institution - 0055Recruiting
- Local Institution - 0037Recruiting
- Local Institution - 0007Recruiting
- Local Institution - 0076
- Local Institution - 0028Recruiting
- Local Institution - 0125Recruiting
- Local Institution - 0129Recruiting
- Local Institution - 0127Recruiting
- Local Institution - 0178
- Fondazione Policlinico Tor VergataRecruiting
- Local Institution - 0088
- Local Institution - 0052Recruiting
- Local Institution - 0075Recruiting
- Azienda Ospedale - Università Padova
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaRecruiting
- Local Institution - 0067
- Local Institution - 0053
- Local Institution - 0143
- Local Institution - 0136Recruiting
- Local Institution - 0154Recruiting
- Local Institution - 0153
- Local Institution - 0130Recruiting
- Local Institution - 0135Recruiting
- Local Institution - 0150Recruiting
- Local Institution - 0124Recruiting
- Local Institution - 0058Recruiting
- Local Institution - 0048Recruiting
- Local Institution - 0036Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0051Recruiting
- Local Institution - 0044
- Local Institution - 0097Recruiting
- Local Institution - 0043
- Local Institution - 0105
- Local Institution - 0106
- Local Institution - 0112Recruiting
- Local Institution - 0109Recruiting
- Local Institution - 0107Recruiting
- Local Institution - 0111Recruiting
- Local Institution - 0110Recruiting
- Local Institution - 0108Recruiting
- Local Institution - 0117
- Karolinska Universitetssjukhuset HuddingeRecruiting
- Local Institution - 0113
- Local Institution - 0119Recruiting
- Local Institution - 0077
- Local Institution - 0066
- Local Institution - 0139
- Local Institution - 0138
- Local Institution - 0140
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part I - Oral-Aza (Dose 1)
Part I - Oral-Aza (Dose 2)
Part II - Oral-Aza (RP3D)
Part II - Placebo
Arm Description
RP3D: Recommended Phase 3 Dose
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Phase 2
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Phase 2 and 3
Secondary Outcome Measures
Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles
Phase 2 and Phase 3
Overall Response is defined as complete response (CR), partial remission (PR), marrow complete response (mCR), hematologic improvement-erythroid response (HI-E), hematologic improvement-platelet response (HI-P), or hematologic improvement-neutrophil response (HI-N) as per IWG 2006 criteria
Number of participants who achieved 84-day packed red blood cells transfusion independence (pRBC-TI)
Phase 2 and Phase 3
pRBC-TI duration
Phase 2 and Phase 3
Number of participants who achieve 84 day platelet transfusion independence (PLT-TI) within 6 cycles
Phase 2 and Phase 3
PLT-TI duration
Phase 2 and Phase 3
Number of participants who achieved pRBC transfusion reduction
Phase 3
pRBC transfusion reduction duration
Phase 3
CR duration
Phase 2 and Phase 3
Best OR
Phase 2 and Phase 3
OR duration
Phase 2 and Phase 3
Overall Survival (OS)
Phase 3
Event-free Survival (EFS)
Phase 3
Time to acute myeloid leukemia (AML)
Phase 3
Time to subsequent therapy
Phase 3
Iron parameters measured from blood
Phase 3
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Phase 3
Summary statistics for Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales and subscales at each assessment point for each treatment arm
Phase 3
Summary statistics for Quality of Life in Myelodysplasia Scale (QUALMS) scales and subscales at each assessment point for each treatment arm
Phase 3
Summary statistics for the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scales and subscales at each assessment point for each treatment arm
Phase 3
Number of participants with healthcare resource use associated with the investigational product (IP)
Phase 3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05469737
Brief Title
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Official Title
A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
July 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
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 safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Anemia, Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part I - Oral-Aza (Dose 1)
Arm Type
Experimental
Arm Title
Part I - Oral-Aza (Dose 2)
Arm Type
Experimental
Arm Title
Part II - Oral-Aza (RP3D)
Arm Type
Experimental
Arm Description
RP3D: Recommended Phase 3 Dose
Arm Title
Part II - Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oral Azacitidine
Other Intervention Name(s)
BMS-986345, Oral-Aza, ONUREG®
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo for Oral Azacitidine
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Description
Phase 2
Time Frame
6 cycles plus 28 days (up to 24 weeks)
Title
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Description
Phase 2 and 3
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles
Description
Phase 2 and Phase 3
Overall Response is defined as complete response (CR), partial remission (PR), marrow complete response (mCR), hematologic improvement-erythroid response (HI-E), hematologic improvement-platelet response (HI-P), or hematologic improvement-neutrophil response (HI-N) as per IWG 2006 criteria
Time Frame
Up to 24 weeks
Title
Number of participants who achieved 84-day packed red blood cells transfusion independence (pRBC-TI)
Description
Phase 2 and Phase 3
Time Frame
Up to 32 weeks
Title
pRBC-TI duration
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
Number of participants who achieve 84 day platelet transfusion independence (PLT-TI) within 6 cycles
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
PLT-TI duration
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
Number of participants who achieved pRBC transfusion reduction
Description
Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
pRBC transfusion reduction duration
Description
Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
CR duration
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
Best OR
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
OR duration
Description
Phase 2 and Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
Overall Survival (OS)
Description
Phase 3
Time Frame
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Title
Event-free Survival (EFS)
Description
Phase 3
Time Frame
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Title
Time to acute myeloid leukemia (AML)
Description
Phase 3
Time Frame
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Title
Time to subsequent therapy
Description
Phase 3
Time Frame
Up to 5 years after discontinuation of Investigational Product, approximately 6 years
Title
Iron parameters measured from blood
Description
Phase 3
Time Frame
Over the course of the study, an average of 1 year
Title
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Description
Phase 3
Time Frame
Up to end of treatment/early termination, an average of 1 year
Title
Summary statistics for Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales and subscales at each assessment point for each treatment arm
Description
Phase 3
Time Frame
Up to end of treatment/early termination, an average of 1 year
Title
Summary statistics for Quality of Life in Myelodysplasia Scale (QUALMS) scales and subscales at each assessment point for each treatment arm
Description
Phase 3
Time Frame
Up to end of treatment/early termination, an average of 1 year
Title
Summary statistics for the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scales and subscales at each assessment point for each treatment arm
Description
Phase 3
Time Frame
Up to end of treatment/early termination, an average of 1 year
Title
Number of participants with healthcare resource use associated with the investigational product (IP)
Description
Phase 3
Time Frame
Over the course of the study, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).
MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria:
Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent
Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MIKKAEL SEKERES, Site 0137
Phone
305-243-9974
Facility Name
Advanced Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumit Sawhney, Site 0147
Phone
954-204-0052
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rami komrokji, Site 0095
Phone
513-504-9712
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Mattour, Site 0174
Phone
313-433-1718
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hematology-Oncology Associates of Central New York, PC
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajeet Gajra, Site 0132
Phone
315-425-3456
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie Traer, Site 0096
Phone
503-494-3553
Facility Name
AHN West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Fazal, Site 0073
Phone
412-578-4355
Facility Name
Charleston Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Withdrawn
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpan Shah, Site 0086
Phone
832-776-5668
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Garcia-Manero, Site 0014
Phone
713-745-3428
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Individual Site Status
Withdrawn
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Shafer, Site 0123
Phone
571-472-1043
Facility Name
Local Institution - 0070
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0070
Facility Name
Local Institution - 0039
City
ABB
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0021
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0016
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0022
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0050
City
Buenos Aires
ZIP/Postal Code
CP1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0144
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0145
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0145
Facility Name
Local Institution - 0146
City
Nowra
State/Province
New South Wales
ZIP/Postal Code
2541
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0146
Facility Name
Local Institution - 0006
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0069
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0018
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0004
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0003
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0034
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0029
City
Vienna
State/Province
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0074
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0074
Facility Name
Local Institution - 0091
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0091
Facility Name
Local Institution - 0008
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0015
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0090
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0090
Facility Name
Local Institution - 0171
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0171
Facility Name
Local Institution - 0167
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0167
Facility Name
Local Institution - 0156
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0156
Facility Name
Local Institution - 0157
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430058
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0157
Facility Name
Local Institution - 0168
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0168
Facility Name
Local Institution - 0162
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0162
Facility Name
Local Institution - 0163
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0163
Facility Name
Local Institution - 0179
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0179
Facility Name
Local Institution - 0166
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0166
Facility Name
Local Institution - 0160
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0160
Facility Name
Local Institution - 0169
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0169
Facility Name
Local Institution - 0164
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0164
Facility Name
Local Institution - 0165
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0165
Facility Name
Local Institution - 0141
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0141
Facility Name
Local Institution - 0161
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0161
Facility Name
Local Institution - 0170
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0170
Facility Name
Local Institution - 0009
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0060
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0045
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0115
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0115
Facility Name
Local Institution - 0116
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0116
Facility Name
Local Institution - 0114
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0114
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau, Site 0025
Phone
33492039268
Facility Name
CHU Bordeaux Haut-Leveque
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dimicoli-Salazar, Site 0063
Phone
33557656511
Facility Name
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Gyan, Site 0024
Phone
+33247473712
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sylvain thepot, Site 0094
Phone
33608029517
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Goursaud, Site 0056
Phone
+33299285547
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe WILLEKENS, Site 0085
Phone
0142114211
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FENAUX, Site 0082
Phone
+33171207022
Facility Name
Local Institution - 0059
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0081
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47166
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0081
Facility Name
Local Institution - 0128
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40479
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0128
Facility Name
Local Institution - 0055
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
Facility Name
Local Institution - 0037
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0007
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0076
City
Kempten
ZIP/Postal Code
87439
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0076
Facility Name
Local Institution - 0028
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0125
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0125
Facility Name
Local Institution - 0129
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0129
Facility Name
Local Institution - 0127
City
Alexandroupolis
ZIP/Postal Code
08100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0127
Facility Name
Local Institution - 0178
City
Hksar
ZIP/Postal Code
0
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0178
Facility Name
Fondazione Policlinico Tor Vergata
City
Rome
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Voso, Site 0061
Phone
390620903210
Facility Name
Local Institution - 0088
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0088
Facility Name
Local Institution - 0052
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0075
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0075
Facility Name
Azienda Ospedale - Università Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianni Binotto, Site 0089
Phone
+39.0498217809
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania Paolini, Site 0101
Phone
+393392231941
Facility Name
Local Institution - 0067
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0067
Facility Name
Local Institution - 0053
City
Reggio Calabria
ZIP/Postal Code
89133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0143
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0143
Facility Name
Local Institution - 0136
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8068501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0136
Facility Name
Local Institution - 0154
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0154
Facility Name
Local Institution - 0153
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0153
Facility Name
Local Institution - 0130
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0130
Facility Name
Local Institution - 0135
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0135
Facility Name
Local Institution - 0150
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0150
Facility Name
Local Institution - 0124
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0124
Facility Name
Local Institution - 0058
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0048
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0036
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0012
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0051
City
Jung-gu
State/Province
Taegu-Kwangyǒkshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0044
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0097
City
Olsztyn
State/Province
Warmińsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0097
Facility Name
Local Institution - 0043
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0105
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0105
Facility Name
Local Institution - 0106
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0106
Facility Name
Local Institution - 0112
City
Ourense
State/Province
Ourense [Orense]
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0112
Facility Name
Local Institution - 0109
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0109
Facility Name
Local Institution - 0107
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0107
Facility Name
Local Institution - 0111
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0111
Facility Name
Local Institution - 0110
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0110
Facility Name
Local Institution - 0108
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0108
Facility Name
Local Institution - 0117
City
Lund
State/Province
Skåne Län [se-12]
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0117
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
State/Province
Stockholms Län [se-01]
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnus Tobiasson, Site 0118
Phone
0858580000
Facility Name
Local Institution - 0113
City
Gothenburg
State/Province
Västra Götalands Län [se-14]
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0113
Facility Name
Local Institution - 0119
City
Örebro
State/Province
Örebro Län [se-18]
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0119
Facility Name
Local Institution - 0077
City
st.Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Local Institution - 0066
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0139
City
Pendik
State/Province
İstanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0139
Facility Name
Local Institution - 0138
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0138
Facility Name
Local Institution - 0140
City
Samsun
ZIP/Postal Code
55270
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0140
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
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