UMIN ID: UMIN000001151
Registered date:12/05/2008
Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | acute leukemia or myelodysplastic syndrome |
| Date of first enrollment | 2008/01/01 |
| Target sample size | 110 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | cyclosporine tacrolimus |
Outcome(s)
| Primary Outcome | Success difined as 1) alive at day 100, 2) absence of grade II-IV acute GVHD, 3) discontinuation of assigned immunosuppressant, and 4) use of steroid. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 55years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Uncontrolled DM, HTN, and so on. |
Related Information
| Primary Sponsor | KSGCT |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | KSGCT |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| ycanda-tky@umin.ac.jp | |
| Affiliation | KSGCT Trial office |
| scientific contact | |
| Name | Shinichiro Okamoto |
| Address | Tokyo Japan |
| Telephone | |
| Affiliation | KSGCT Chairman |