Randomized trial comparing 7 day and 5 day schedule of azacitidine for high-risk MDS -JALSG MDS212-

Randomized trial comparing 7 day and 5 day schedule of azacitidine for high-risk MDS -JALSG MDS212- - JALSG MDS212

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009633

Enrollment

410

Registered

2012-12-26

Start date

2012-12-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndromes (RAEB and RAEB-t in FAB classification)

Interventions

azacitidine 75mg/m2, 5 days azacitidine 75mg/m2, 7 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) RAEB or RAEB-t of MDS in FAB classification (2) Survival more than 3 months is expected (3) No previous treatment with azacitidine, chemotherapy, transplantation, or lenalidomide (4) 16-years old or older (5) No candidate of hematopoietic stem cell transplantation (6) Performance status (ECOG) 0-2 (7) Enough organ function (8) With written informed consent

Exclusion criteria

Exclusion criteria: (1) AML with recurrent cytogenetic abnormality in WHO classification (2) With active malignancy (3) DM with poor control (4) With active infection (5) Under control with major tranquilizer (6) Pregnant women (7) Infection with HBV, HCV, or HIV (8) Those evaluated ineligible by attending doctors

Design outcomes

Primary

Measure	Time frame
2-year overall survival	—

Countries

Japan

Contacts

Public ContactYasushi Miyazaki

Nagasaki University Atomic Bomb Disease Institute Department of Hematology

jalsgsc@hama-med.ac.jp+81-(0)95-819-7111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026