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)

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

December 14, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

July 29, 2026

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Oral Azacitidine

Specified dose on specified days

DRUG

Placebo for Oral Azacitidine

Specified dose on specified days

Trial Locations (65)

0

Local Institution - 0178, Hksar

1425

Local Institution - 0016, Buenos Aires

1431

Local Institution - 0022, Buenos Aires

1629

Local Institution - 0070, Pilar

3000

Local Institution - 0018, Melbourne

3004

Local Institution - 0003, Melbourne

3065

Local Institution - 0004, Melbourne

3168

Local Institution - 0006, Clayton

8200

Local Institution - 0115, Aarhus

9000

Local Institution - 0116, Aalborg

12462

Local Institution - 0125, Chaïdári

13057

Local Institution - 0132, East Syracuse

15224

Local Institution - 0073, Pittsburgh

18012

Local Institution - 0107, Granada

20089

Local Institution - 0052, Rozzano

22031

Local Institution - 0123, Fairfax

22081

Local Institution - 0007, Hamburg

28006

Local Institution - 0111, Madrid

32005

Local Institution - 0112, Ourense

33011

Local Institution - 0110, Oviedo

33136

Local Institution - 0137, Miami

33321

Local Institution - 0147, Tamarac

33600

Local Institution - 0063, Pessac

37007

Local Institution - 0108, Salamanca

37032

Local Institution - 0024, Tours

40138

Local Institution - 0101, Bologna

40479

Local Institution - 0128, Düsseldorf

41944

Local Institution - 0051, Junggu

46010

Local Institution - 0109, Valencia

47166

Local Institution - 0081, Duisburg

49933

Local Institution - 0094, Angers

50134

Local Institution - 0075, Florence

58128

Local Institution - 0058, Hwasun Gun

59000

Local Institution - 0056, Lille

73557

Local Institution - 0028, Mutlangen

75010

Local Institution - 0082, Paris

77030

Local Institution - 0014, Houston

Local Institution - 0086, Houston

94805

Local Institution - 0085, Villejuif

430030

Local Institution - 0156, Wuhan

8068501

Local Institution - 0136, Kitakyushu-shi

C1199ABB

Local Institution - 0039, ABB

CP1280AEB

Local Institution - 0050, Buenos Aires

M4N 3M5

Local Institution - 0008, Toronto

M5G 2M9

Local Institution - 0015, Toronto

H4A 3J1

Local Institution - 0090, Montreal

500 05

Local Institution - 0060, Hradec Králové

04103

Local Institution - 0055, Leipzig

01307

Local Institution - 0037, Dresden

570 10

Local Institution - 0129, Thessaloniki

08100

Local Institution - 0127, Alexandroupoli

NT

Local Institution - 0180, Shatin

00133

Local Institution - 0061, Rome

064-0804

Local Institution - 0154, Sapporo

660-8550

Local Institution - 0153, Amagasaki

252-0375

Local Institution - 0130, Sagamihara

980-8574

Local Institution - 0135, Sendai

141-8625

Local Institution - 0150, Shinagawa-ku

545-8586

Local Institution - 0124, Osaka

10-228

Local Institution - 0097, Olsztyn

06591

Local Institution - 0048, Seoul

05505

Local Institution - 0036, Seoul

06351

Local Institution - 0012, Seoul

141 86

Local Institution - 0118, Stockholm

701 85

Local Institution - 0119, Örebro

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT05469737 - 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) | Biotech Hunter | Biotech Hunter