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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033115
Enrollment
Unknown
Registered
2020-05-21
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

experimental group:Azacitidine: 35 mg-75mg/m2 Subcutaneous injection one time/day, consecutively 7 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. Patients between the ages of 18-60, male and female are not limited; 2. Patients without severe gravity, lung, liver and kidney diseases; 3. Patients with high-risk MDS or AML who received allogeneic transplantation for one month; 4. MRD positive patients were reexamined at any time after high-risk MDS or AML transplantation; 5. Each condition should meet the basic normal blood routine; 6. Patients who are able to understand and willing to sign the informed consent of this trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with uncontrolled heart failure, unstable angina, arrhythmia or mental disease; 3. Patients with uncontrollable infectious diseases; 4. HIV infected patients; 5. Patients with stage 3 or above chronic kidney disease; 6. Patients with recurrence of basic diseases.

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 ContactWang Li

The First Affiliated Hospital of Chongqing Medical University

5640326@qq.com+8618623015252

Outcome results

None listed

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