Early Tapering of MMF after High Risk Allo-HSCT
Phase 2
Recruiting
- Conditions
- acute leukemia, myelodysplastic syndrome
- Registration Number
- JPRN-jRCTs051180097
- Lead Sponsor
- Minami Hironobu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
1) undergo allogeneic hematopoietic stem cell transplantation 2) between 16 and 69 years old 3) 8/8 matched or 7/8 matched (DRB1 mismatched) donor 4) acute leukemia or MDS 5) normal organ function 6) written informed consent
Exclusion Criteria
1) cord blood transplantation 2) uncontrolled hypertension 3) positive for anti HIV antibody 4) uncontrolled active infection 5) uncontrolled CNS disease 6) pregnant or breast-feeding woman 7) judged inappropriate perticipants for this study by their attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival rate at 1 year after HSCT
- Secondary Outcome Measures
Name Time Method 1) relapse rate and non-relapse mortality rate at 1 year after HSCT 2) overall survival, relapse and non-relapse mortality rate at 100 days after HSCT 3) cumulative incidence of acute GVHD 4) cumulative incidence of chronic GVHD 5) treatment related toxicity 6) time until neutrophil and platelet engraftment 7) cumulative incidence of infection