Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia

UMIN ID: UMIN000000511

Registered date:01/11/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute Myeloid Leukemia
• Date of first enrollment: 2006/11/01
• Target sample size: 254
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Two common courses of remission induction multi-agent combination chemotherapy for all the eligible patients. For Low Risk group (LR), 3 courses of intensification multi-agent combination chemotherapy. For Intermediate Risk group (IR), 3 courses of intensification multi-agent combination chemotherapy. For High Risk group (HR), 1 to 3 courses of intensification multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation.

Outcome(s)

• Primary Outcome: Three-year event-free survival rate of the each risk group
• Secondary Outcome: For the each risk group, 3-year EFS; rate of adverse events defined by Common Terminology Criteria for Adverse Events(CTCAE) ver3.0; compliance rate of protocol specified regimen. Overall, 3-year EFS and OS; induction remission rate; remission rate after initial course of induction chemotherapy; compliance rate of protocol specified regimen.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: 1)CNS hemorrhage which is likely to interfere protocol therapy 2)uncontrolled DM 3)severe mental abnormalities 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)any inappropriate status judged by physician

Related Information

• Primary Sponsor: Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare