A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
Phase 1
- Conditions
- Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma
- Registration Number
- JPRN-C000000253
- Lead Sponsor
- Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Positivity for HBs antigen and/or HIV antibody 3) Active lesions in CNS 4) Active infections 5) Patients who are considered as inappropriate with other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eutrophil engraftment within 35 days after transplantation (Phase I) Overall survival at day 100 after transplantion (Phase II)
- Secondary Outcome Measures
Name Time Method Incidence and severity of acute GVHD Incidence and severity of chonic GVHD Overall survival at 1 year after transplantation Diase free survival at 1 year after transplantation Treatment related mortality at 1 year after transplantation Incidence and severity of infectious disease after transplantation Immune reconstitution after transplantation