Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation.
Not Applicable
- Conditions
- Myelodysplastic syndrome(MDS)
- Registration Number
- JPRN-UMIN000018791
- Lead Sponsor
- Kanto Study Group for Cell Therapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Allergic to azacitidine (2) With active uncontrollable infectious diseases (3) With severe mental disorder (4) With severe acute GHVD Grade III to IV (5) Requiring 2nd line therapy for acute GVHD due to unsuccessful 1st line therapy (6) Uncontrollable chronic GVHD (7) Under treatment of anti-CMV drug (8) Those evaluated ineligible by attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate of feasible initial dose Completion rate of total 4 cycles
- Secondary Outcome Measures
Name Time Method (1) Incidence of dose limiting toxicity (2) Incidence of adverse events (3) Time to progression