Spots Global Cancer Trial Database for 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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Trial Identification
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 ID: NCT05469737
Conditions
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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0137, Miami, Florida, United States
Local Institution - 0147, Tamarac, Florida, United States
Local Institution - 0132, East Syracuse, New York, United States
Local Institution - 0073, Pittsburgh, Pennsylvania, United States
Local Institution - 0014, Houston, Texas, United States
Local Institution - 0086, Houston, Texas, United States
Local Institution - 0123, Fairfax, Virginia, United States
Local Institution - 0070, Pilar, Buenos Aires, Argentina
Local Institution - 0039, ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0016, Buenos Aires, , Argentina
Local Institution - 0022, Buenos Aires, , Argentina
Local Institution - 0050, Buenos Aires, , Argentina
Local Institution - 0006, Clayton, Victoria, Australia
Local Institution - 0018, Melbourne, Victoria, Australia
Local Institution - 0004, Melbourne, Victoria, Australia
Local Institution - 0003, Melbourne, , Australia
Local Institution - 0008, Toronto, Ontario, Canada
Local Institution - 0015, Toronto, Ontario, Canada
Local Institution - 0090, Montréal, Quebec, Canada
Local Institution - 0171, Beijing, Beijing, China
Local Institution - 0156, Wuhan, Hubei, China
Local Institution - 0166, Shenyang, Liaoning, China
Local Institution - 0060, Hradec Kralove, , Czechia
Local Institution - 0115, Aarhus, Midtjylland, Denmark
Local Institution - 0116, Aalborg, Nordjylland, Denmark
Local Institution - 0063, Pessac, Aquitaine, France
Local Institution - 0024, Tours, Indre-et-Loire, France
Local Institution - 0094, Angers, Maine-et-Loire, France
Local Institution - 0056, Lille, Nord, France
Local Institution - 0085, Villejuif, Val-de-Marne, France
Local Institution - 0082, Paris, , France
Local Institution - 0081, Duisburg, Nordrhein-Westfalen, Germany
Local Institution - 0128, Düsseldorf, Nordrhein-Westfalen, Germany
Local Institution - 0055, Leipzig, Sachsen, Germany
Local Institution - 0037, Dresden, , Germany
Local Institution - 0007, Hamburg, , Germany
Local Institution - 0028, Mutlangen, , Germany
Local Institution - 0125, Chaidari, Attikí, Greece
Local Institution - 0129, Thessaloniki, Thessaloníki, Greece
Local Institution - 0127, Alexandroupolis, , Greece
Local Institution - 0178, Hksar, , Hong Kong
Local Institution - 0180, Shatin, , Hong Kong
Local Institution - 0061, Rome, Lazio, Italy
Local Institution - 0052, Rozzano, Milano, Italy
Local Institution - 0075, Firenze, Toscana, Italy
Local Institution - 0101, Bologna, , Italy
Local Institution - 0136, Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0154, Sapporo, Hokkaido, Japan
Local Institution - 0153, Amagasaki, Hyogo, Japan
Local Institution - 0130, Sagamihara, Kanagawa, Japan
Local Institution - 0135, Sendai-shi, Miyagi, Japan
Local Institution - 0150, Shinagawa-ku, Tokyo, Japan
Local Institution - 0124, Osaka, , Japan
Local Institution - 0058, Hwasun Gun, Jeonranamdo, Korea, Republic of
Local Institution - 0048, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0036, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0012, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0051, Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of
Local Institution - 0097, Olsztyn, Warmińsko-mazurskie, Poland
Local Institution - 0109, Valencia, Valenciana, Comunitat, Spain
Local Institution - 0107, Granada, , Spain
Local Institution - 0111, Madrid, , Spain
Local Institution - 0112, Orense, , Spain
Local Institution - 0110, Oviedo, , Spain
Local Institution - 0108, Salamanca, , Spain
Local Institution - 0118, Stockholm, Stockholms Län [se-01], Sweden
Local Institution - 0119, Örebro, Örebro Län [se-18], Sweden
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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