Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome - Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005662

Enrollment

Registered

2011-05-30

Start date

2011-05-01

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

low-risk myelodysplastic syndrome

Interventions

The dosage is 75mg/m2 of azacitidine by subcutaneous injection or intravenous infusion for 10 minutes once daily for 7 days every four weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with low risk MDS (RA, RARS) according to FAB classification and is considered by investigator to be adequate for this study, meeting at least one of three following criteria. i) a packed red blood cell transfusion history in 3 months (12 weeks) prior to the enrollment ii) platelet count less than 50,000/mm3 or clinically meaningful bleeding symptoms iii) neutrophil count less than 1,000/mm3 and increased susceptibility to infection (requiring use of antibiotics) 2. Patients with a life expectancy of at least 3 months at the time of enrollment 3. Patients with no prior administration of azacitidine-based treatment (Chemotherapy, HSCT, Lenalidomide, Imuunosuppressive therapy, Anabolic steroids therapy, Iron-chelation therapy, Vitamin D and Vitamin K are allowed) 4. Age: 20 years and over 5. Patients who is not planned for allo-HSCT. 6. Patients with ECOG performance status of 0-2 7. Patients with clinically adequate hepatic, renal and heart function defined as follows i) Serum total bilirubin less than 2.0 mg/dl ii) Serum creatinine less than 2.0 mg/dl iii) PaO2 more than 60 Torr or SaO2 more than 93% while breathing room air. iv) no severe ECG abnormalities. 8. Patients who can be hospitalized during at least 1st cycle. 9. Patients who has given a written informed consent for this study (including contraception).

Exclusion criteria

Exclusion criteria: 1. Patients with simultaneous multiple cancers. 2. Patients with history of hyper- sensitivity to mannitol 3. Patients with poorly-controlled infection requiring intensive care with antibiotics and antifungals. 4. Patients with poorly-controlled diabetes. 5. Patients with severe psychiatric disorder. 6. Pregnant or lactating females. 7. Patients with positive serology for HBs antigen, HCV antibody or HIV antibody. 8. Patients who is deemed as ineligible for this study by investigator.

Design outcomes

Primary

Measure	Time frame
hematological improvement	—

Secondary

Measure	Time frame
1. hematological remission 2. transfusion dependency 3. hematological improvement in each chromosomal karyotype 4. progression stage (WT1) 5. continuity of therapy 6. adverse events	—

Countries

Japan

Contacts

Public ContactMitsuhiro Matsuda, MD, PhD

PL General Hospital Department of Hematology

matsuda@plhospital.or.jp0721-23-7805

Outcome results

None listed

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