Single agent graft-versus-host disease prophylaxis with post-transplant cyclophosphamide for stem cell transplantation: a phase II study (SAP-P2)
Not Applicable
Recruiting
- Conditions
- Acute leukemia
- Registration Number
- JPRN-UMIN000021375
- Lead Sponsor
- ational Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Prior allogeneic stem cell transplantation 2. Effusion with grade 2 or worse at CTCAE ver 4.0 3. Uncontrolled infection 4. Severe psychological disorders 5. Pregnant or suspected pregnancy 6. Not eligible for this study at the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of graft-versus-host disease at day 100
- Secondary Outcome Measures
Name Time Method 1. Engraftment probability at day 30 2. Non-relapse mortality at day 100 3. Incidence of infectious disease at week 8 4. Reconstruction of immune status 5. Time from transplantation to onset of chronic GVHD 6. Time from transplantation to relapse 7. Time from transplantation to death