Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

UMIN ID: UMIN000000645

Registered date:19/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute promyelocytic leukemia
• Date of first enrollment: 2006/04/01
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Five courses of multi-agent combination chemotherapy (2 courses for remission induction and 3 for intensification) consisted of ATRA, anthracyclines, and cytarabine, followed by single-agent maintenance chemotherapy of ATRA for all the eligible patients.

Outcome(s)

• Primary Outcome: Three-year event-free survival rate
• Secondary Outcome: Remission induction rate Three-year overall survival rate Rate of adverse events Rate of DIC or retinoic acid syndrome in the first remission induction therapy Rate of mortality in the first remission induction therapy Three-year CNS relapse rate

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: CNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis Pregnancy Septic shock History of organ transplantation History of congenital or acquired immunodeficiency 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