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

Phase 2

• Conditions: Acute promyelocytic leukemia

• Registration Number: JPRN-UMIN000000645
• Lead Sponsor: Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-19
• Study Completion: 2014-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Three-year event-free survival rate

Secondary Outcome Measures

Name	Time	Method
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