UMIN ID: UMIN000000989
Registered date:22/01/2008
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Acute myeloid Leukemia Myelodysplastic syndrome |
| Date of first enrollment | 2008/01/01 |
| Target sample size | 73 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Single common courses of remission induction multi-agent combination chemotherapy for all the eligible patients For Standard Risk group(SR), 4 courses of intensification multi-agent combination chemotherapy For High Risk group(HR), 2 courses of remission induction multi-agent combination chemotherapy followed by 4 courses of intensification multi-agent combination chemotherapy |
Outcome(s)
| Primary Outcome | Two-year event-free survival rate |
|---|---|
| Secondary Outcome | Remission rate after initial induction chemotherapy Remission rate for high risk group Three-year overall survival rate Two-year event free survival for each risk group Three-year overall survival for each risk group Incidence of FLT3-ITD Two-year event free survival with or without FLT3-ITD Incidence of adverse events during chemotherapy Compliance rate of protocol specified regimen Three-year event free survival of the patients less than 4 years old |
Key inclusion & exclusion criteria
| Age minimum | 4months-old |
|---|---|
| Age maximum | 216months-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)CNS hemorrhage which is likely to intervent protocol therapy 2)uncontrolled DM 3)uncontrolled cardiac failure 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)CNS leukemia 8)any inappropriate status judged by physician |
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 | Takashi Taga |
| Address | Seta-tsukinowa, Otsu, Shiga, 520-2192 Japan |
| Telephone | 077-548-2228 |
| ttaga@belle.shiga-med.ac.jp | |
| Affiliation | Shiga University of Medical Science Departiment of Pediatrics |
| scientific contact | |
| Name | Takashi Taga |
| Address | Seta-tsukinowa, Otsu, Shiga Japan |
| Telephone | 077-548-2228 |
| ttaga@belle.shiga-med.ac.jp | |
| Affiliation | Shiga University of Medical Science Department of Pediatrics |