Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-R11: Multi-center Phase II Study of the efficacy and the safety in the induction chemotherapy containing fludarabine for children with the first bone marrow relapse and induction failure of acute myeloid leukemia.

Phase 2

• Conditions: acute myeloid leukemia

• Registration Number: JPRN-UMIN000007390
• 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: 2012-03-01
• Study Completion: 2015-11-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. isolated extramedullary relapse 2. history of allogeneic stem cell transplantation 3. history of FLAG therapy 4. any complication listed below; active or unmanageable infectious disease, severe CNS bleeding(example; CTCAE Ver. 4.0; grade 3 or more, uncontrolled DM, severe mental abnormalities, heart diseases, hemophillia, autoimmune diseases 5. pregnancy 6. history of congenital or acquirede immunodeficiency 7. contraindication of cytosine arbinoside or idarubicin 8. administration of anti-cancer agent within 14 days of the enrollment 9. unusual treatment schedule or intermission in the first induction chemotherapy for AML because of personal request etc 10. any inappropriate status judged by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of bone marrow remission after the treatment regimen

Secondary Outcome Measures

Name	Time	Method
Positive rate of MRD by FACS after the treatment regimen Two-year event free survival rate and over all survival rate Rate of remission, two-year event free survival and over all survival between the first bone marrow relapse patients and induction failure patients Rate of remission, two-year event free survival and over all survival among times of relapse and chromosomal abnormalities Rate of adverse events (CTCAE ver.4.0, grade 3 or more) Rate of accomplishment of the protocol Rate of early death