Myelodysplastic Syndrome Clinical 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)

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).

View Eligibility Criteria

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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT05469737

Recruitment Status:

Not yet recruiting

Sponsor:

Bristol-Myers Squibb

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There are 34 Locations for this study

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Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
rami komrokji, Site 0095
Contact
513-504-9712
Hematology-Oncology Associates of Central New York, PC
East Syracuse New York, 13057, United States More Info
Ajeet Gajra, Site 0132
Contact
315-425-3456
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Elie Traer, Site 0096
Contact
503-494-3553
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Afaf Osman, Site 0134
Contact
801-646-4064
Local Institution - 0070
Pilar Buenos Aires, 1629, Argentina More Info
Site 0070
Contact
Local Institution - 0050
Buenos Aires , CP128, Argentina More Info
Site 0050
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Local Institution - 0019
La Plata , 1900, Argentina
Local Institution - 0003
Melbourne Victoria, 3004, Australia More Info
Site 0003
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Local Institution - 0034
Linz Oberösterreich, 4020, Austria More Info
Site 0034
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Local Institution - 0029
Vienna Wien, 1140, Austria More Info
Site 0029
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Local Institution - 0074
Salzburg , 5020, Austria More Info
Site 0074
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Local Institution - 0008
Toronto Ontario, M4N 3, Canada More Info
Site 0008
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Local Institution - 0015
Toronto Ontario, M5G 2, Canada More Info
Site 0015
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Local Institution - 0025
Nice Alpes-Maritimes, 06202, France More Info
Site 0025
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Local Institution - 0063
Pessac Aquitaine, 33600, France More Info
Site 0063
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Local Institution - 0026
Marseille Bouches-du-Rhône, 13273, France More Info
Site 0026
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Local Institution - 0024
Tours Indre-et-Loire, 37032, France More Info
Site 0024
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Local Institution - 0094
Angers Maine-et-Loire, 49933, France More Info
Site 0094
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Local Institution - 0056
Lille Nord, 59000, France More Info
Site 0056
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Local Institution - 0085
Villejuif Val-de-Marne, 94800, France More Info
Site 0085
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Local Institution - 0082
Paris , 75010, France More Info
Site 0082
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Local Institution - 0028
Mutlangen Baden-Württemberg, 73557, Germany More Info
Site 0028
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Local Institution - 0059
Munich Bayern, 81675, Germany More Info
Site 0059
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Local Institution - 0081
Duisburg Nordrhein-Westfalen, 47166, Germany More Info
Site 0081
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Local Institution - 0037
Dresden Sachsen, 01307, Germany More Info
Site 0037
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Local Institution - 0055
Leipzig Sachsen, 04103, Germany More Info
Site 0055
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Local Institution - 0007
Hamburg , 22081, Germany More Info
Site 0007
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Local Institution - 0076
Kempten , 87439, Germany More Info
Site 0076
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Local Institution - 0061
Rome Lazio, 00133, Italy More Info
Site 0061
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Local Institution - 0048
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of More Info
Site 0048
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Local Institution - 0036
Seoul Seoul-teukbyeolsi, 05505, Korea, Republic of More Info
Site 0036
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Local Institution - 0097
Olsztyn Warmińsko-mazurskie, 10-22, Poland More Info
Site 0097
Contact
Local Institution - 0043
Katowice Śląskie, 40-51, Poland More Info
Site 0043
Contact

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT05469737

Recruitment Status:

Not yet recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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