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Clinical study of different doses decitabine treating intermediate/high risk MDS.

Clinical study of standard and lower doses decitabine treating intermediate/high risk patients with myelodysplastic syndrome (MDS).

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002004
Enrollment
Unknown
Registered
2012-03-09
Start date
2009-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Myelodysplastic synrome

Interventions

1:20mg/m2, infused intravenously over 1 hour daily on 5 consecutive days, every 4 weeks 1 course
2:15(±1)mg/m2, infused intravenously over 1 hour daily on 5 consecutive days, every 4 weeks 1 course

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 16 to 90 years; 2. diagnosis of intermediate/high risk MDS, and IPSS >=0.5; 3. A performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG); 4. no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases; 5. adequate hepatic (serum bilirubin level <2*upper normal limit) and renal (serum creatinine <2*upper normal limit) function tests; 6. Signed informed consent indicating that patients are aware of the clinical trail of this study.

Exclusion criteria

Exclusion criteria: 1. age 90 years; 2. Female with pregnancy; 3. a performance of 4-5 according to ECOG score; 4. HIV positive; 5. uncontrolled severe fungal infection or tuberculosis; 6. with other progressive malignant diseases.

Design outcomes

Primary

MeasureTime frame
overall response rate (ORR);

Secondary

MeasureTime frame
overall survival;hematological adverse effects;treatment safety;

Countries

China

Contacts

Public ContactLi Xiao
lixiao3326@yahoo.cn+86 021 24058745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026