Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15).
Phase 2
Recruiting
- Conditions
- acute myeloid leukemia (AML)
- Registration Number
- JPRN-UMIN000027821
- Lead Sponsor
- Japan Children's Cancer Group (JCCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria 1)Patients who have extramedullary lesions at registry 2)Patients who have prior radiation therapy 3)Patients who have prior hematopoietic cell transplantation 4)Patients who have poorly controlled infectious disease 5)Patients who have psychiatric disorder 6)Patients who have coinciding malignancies 7)Patients who have an episode of hypersensitivity reactions against drugs used in conditioning regimens and/or GVHD prophylaxis 8)Pregnant women or women who may be pregnant 9)Patients who are considered as inappropriate for this trial by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of overall survival rate at three years after transplantation
- Secondary Outcome Measures
Name Time Method