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Evaluation of efficacy of decitabine in the maintenance treatment of patients with acute myeloid leukemia/myelodysplastic syndromes after allogeneic hematopoietic stem cell transplantation

Evaluation of efficacy of decitabine in the maintenance treatment of patients with acute myeloid leukemia/myelodysplastic syndromes after allogeneic hematopoietic stem cell transplantation

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024518
Enrollment
Unknown
Registered
2019-07-13
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Myelodysplastic syndrome/Acute myeloid leukemia

Interventions

case series:Decitabine: 10 mg Subcutaneous injection one time/day, consecutively 5 days in a month x 12 times or three months until the MRD becomes negative

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, male or female; 2. high risk MDS or AML treated by allo-HSCT and 1 month after HSCT; 3. MRD(+) after transplantation; 4. Routine blood indexes should be normal in each case; 5. Ability to understand and be willing to sign the informed consent form of this trial.

Exclusion criteria

Exclusion criteria: 1. pregnant women or lactation women; 2. patients with uncontrolled heart failure, unstable angina, arrhythmia or mental disorders; 3. uncontrolled infection disease; 4. HIV infected patients; 5. Patients with 3 or high stage chronic renal disease; 6. Relapse of MDS or AML

Design outcomes

Primary

MeasureTime frame
complete remission state of bone marrow;remission state of hematology ;disappear of extramedullary invasion ;event-free survival;overall survival;cumulative disease rate of relapse ;

Secondary

MeasureTime frame
early mortality rate ;

Countries

China

Contacts

Public ContactLi Wang

The First Affiliated Hospital of Chongqing Medical University

5640326@qq.com+86 18623015252

Outcome results

None listed

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