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Decitabine and unrelated cord blood stem cell transplantation in aged acute myeloid leukemia patients

A single center, prospective, phase III clinical study of the decitabine and unrelated cord blood stem cell transplantation in aged acute myeloid leukemia patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006492
Enrollment
Unknown
Registered
2015-06-02
Start date
2015-07-01
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

Acute myeloid leukemia

Interventions

Study Group:Decitabine+Ara-c+Umbilical cord blood stem cells
Study Group:6-MP+ATRA+vitaminD3

Sponsors

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed AML patients by both morphology and immunology; 2. Rule out APL by morphology and molecular; 3. With complete remission by morphology after induction therapy; 4. To be aged 60~75 years; 5. Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 6. Normal cardiac function: NYHA I/II; 7. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 8. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. APL, treatment related AML; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Contraindication to chemotherapeutics drugs; 5. Liver and renal insufficiency (beyond the inclusion criteria); 6. Heart failure NYHA III/IV, severe arrhythmia and myocardial infarction; 7. Patients with a "currently active" second malignancy; 8. Patients with "currently active" tuberculosis. Patients with HIV; 9. Patients with other hematological disease; 10. Patients with pregnancy or lactation; 11. Patients who can't understand or obey the protocol; 12. Patients with a history of intolerance or allergy to the same kind of medication in the regimen; 13. Patients aged beyond 60~75 years; 14. Patients participated in other clinical trial; 15. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

MeasureTime frame
Disease Free Survival;

Secondary

MeasureTime frame
Overall Survival;Early Death Rate;

Countries

China

Contacts

Public ContactJunmin Li
lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026