UMIN ID: UMIN000001146
Registered date:01/06/2008
Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Adult T cell leukemia/lymphoma |
| Date of first enrollment | 2008/07/01 |
| Target sample size | 26 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Use tacrolimus and short-term methotrexate as a GVHD prophylaxis |
Outcome(s)
| Primary Outcome | Incidence of grade II-IV acute GVHD at 100 days after PBSCT |
|---|---|
| Secondary Outcome | Incidence of chronic GVHD, overall survival rate at 2 years, nonrelapse mortality rate at 2 years, relapse rate at 2 years, treatment-associated toxicity, term to hematopoietic recovery |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Positive for HIV antibody andor HBs antigen (2)T cell depleted transplantation (3)Pregnant or during breast feeding (4)Uncontrolled psychiatric disease (5)Uncontrolled active infection (6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen (7)A history of intravenous chemotherapy within 21 days before transplantation (8)Cases that physicians judged as inappropriate |
Related Information
| Primary Sponsor | Nagoya Blood and Marrow Transplantation Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshihiro Inamoto |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-744-2145 |
| yinamoto@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Department of Hematology and Oncology |
| scientific contact | |
| Name | Koichi Miyamura |
| Address | 3-35 Michishita-cho, Nakamura-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-481-5111 |
| Affiliation | Japanese Red Cross Nagoya First Hospital Department of Hematology |