Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Phase 3
- Conditions
- Acute leukemia, Chronic myeloid leukemia
- Registration Number
- JPRN-C000000186
- 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 complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1. Previous transplantation. 2. Use of T cell depleted marrow. 3. Use of ATG and ALG for preparative regimen. 4. Severe dysfunction of kidney, liver and lung. 5. History of severe cardiac disease 6. History of pancreatitis and diabetes mellitus. 7. Hyperkelemia (>=5.5mEq/l) 8. Hypertension necessitating medication. 9. Active infection (including hepatitis B, hepatitis C, HIV, syphilis) 10. History of allergy or allergic response to drugs 11. Pregnant or lactating woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method