HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Phase 3
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Biological: microtransplantation
- Registration Number
- NCT01484171
- Lead Sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Brief Summary
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Having signed informed consent
- Diagnosis was based on the French-American-British (FAB) and WHO criteria.
- Age ≥ 7 years old
- Age < 60 years old
Exclusion Criteria
1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description microtransplantation microtransplantation The patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells idarubicin idarubicin The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.
- Primary Outcome Measures
Name Time Method complete remission one year
- Secondary Outcome Measures
Name Time Method overall survival three years disease-free survival three years
Trial Locations
- Locations (1)
The Affiliated Hospital of the Chinese Academy of Military Medical Science
🇨🇳Beijing, Beijing, China