UMIN ID: UMIN000002212
Registered date:26/07/2009
Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced stage lymphoblastic lymphoma of children. |
| Date of first enrollment | 2005/02/01 |
| Target sample size | 124 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Treatment regimen has fundamentally BFM backbone and intensified with pulse type early and late maintenance phase, which consisted with MTX, VCR, L-ASP, PSL, 6MP, and CPA. |
Outcome(s)
| Primary Outcome | 3 year event-free survival |
|---|---|
| Secondary Outcome | (1) 3year overall survival (2)Incidence of therapy-rerated severe toxicity |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1, Down's syndrome 2, previous malignancy of any type 3, Prior stem cell or organ transplantation 4, Congenital or acquired immunodeficiency |
Related Information
| Primary Sponsor | Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shosuke Sunami |
| Address | 90-1 Iidacho Narita city Japan Japan |
| Telephone | 0476222311 |
| s-sunami@sc4.so-net.ne.jp | |
| Affiliation | Japanese Red Cross Narita Hospital Department of Pediatrics |
| scientific contact | |
| Name | Shosuke Sunami |
| Address | 90-1 Iidacho Narita city Japan Japan |
| Telephone | 0476222311 |
| s-sunami@sc4.so-net.ne.jp | |
| Affiliation | Japanese Red Cross Narita Hospital Department of Pediatrics |