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Decitabine combined with umbilical cord blood infusion for induction treatment of myelodysplastic syndrome

Single-center clinical study on the efficacy and safety of decitabine combined with umbilical cord blood infusion for induction treatment of myelodysplastic syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035484
Enrollment
Unknown
Registered
2020-08-12
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

myelodysplastic syndrome

Interventions

Case series:decitabine and umbilical cord blood

Sponsors

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. MDS diagnosed by both morphology and immunology; 2. Aged 18 to 60 years; 3.Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 4. Normal cardiac function; 5. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 6. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Treatment related MDS; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Contraindications to chemotherapy drugs; 5. Abnormal liver and kidney function, exceeding the entry criteria; 6. Severe heart disease, including myocardial infarction, heart failure; 7. Patients with a "currently active" second malignancy; 8. Patients with "currently active" tuberculosis. Patients with HIV; 9. Patients with other hematological disease; 10. Pregnant or breastfeeding women; 11. Patients who can't understand or obey the protocol; 12. Past history of intolerance or allergy to similar drugs; 13. Patients participated in other clinical trial; 14. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

MeasureTime frame
Complete Remission Rate;Disease Free Survival;

Secondary

MeasureTime frame
Overall Survival;Minimal Residual Disease;Safety and Toxicity;

Countries

China

Contacts

Public ContactJunmin Li

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology

delijunmin@126.com+86 13817712211

Outcome results

None listed

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