UMIN ID: C000000066
Registered date:17/08/2005
Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | adult T-cell leukemia / lymphoma |
| Date of first enrollment | 1998/08/01 |
| Target sample size | 130 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis. biweekly-CHOP with G-CSF and intrathecal prophylaxis. |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | Toxicity, CR rate, Progression free survival |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Diabetes mellitus necessitating treatment with insulin. 2) Active systemic infection. 3) Cardiac disorders expected to become worse as a result of the DOX-containing regimen. 4) Acute hepatitis, chronic hepatitis or liver rrhosis. 5) Positive for HBs Ag or anti-HCV Ab. 6) Active concurrent malignancy. 7) Other serious medical or psychiatric conditions. 8) Pregnancy or breast feeding. 9) Central nervous system involvement by ATL cells. |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00145002 |
Contact
| public contact | |
| Name | Kunihiro Tsukasaki, MD, PhD |
| Address | 1-12-4 Sakamoto, Nagasaki 852-8523, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9801 Coordinating Office Department of Hematology, Nagasaki University Graduate School of Biomedical Science |
| scientific contact | |
| Name | Masao Tomonaga, MD, PhD |
| Address | 1-12-4 Sakamoto, Nagasaki 852-8523, Japan Japan |
| Telephone | |
| Affiliation | Nagasaki University Graduate School of Biomedical Science Department of Hematology |