UMIN ID: C000000186
Registered date:12/09/2005
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)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute leukemia, Chronic myeloid leukemia |
| Date of first enrollment | 1999/08/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Methotrexate and Tacrolimus (FK506) for GVHD prophylaxis Methotrexate and Cyclosporine A for GVHD prophylaxis |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 50years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Health and Labour Sciences Research Grants,Research on Human Genome,Tissue Engineering,Ministry of Health,Labour and Welfare |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshiko Atsuta |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi, 466-8550, Japan Japan |
| Telephone | 052-745-3116 |
| c-shot@med.nagoya-u.ac.jp | |
| Affiliation | Center for Supporting Hematology-Oncology Trials (C-SHOT) Center for Supporting Hematology-Oncology Trials (C-SHOT) |
| scientific contact | |
| Name | Yoshihisa Kodera |
| Address | 3-35 Michishita-cho Nakamura-ku, Nagoya, Aichi 453-8511, Japan Japan |
| Telephone | |
| Affiliation | Japanese Red Cross Nagoya First Hospital Department of Internal Medicine |