Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
2 other identifiers
interventional
394
1 country
1
Brief Summary
This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2002
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 6, 2011
April 1, 2011
7.1 years
September 12, 2005
April 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate
8-9 years
Secondary Outcomes (1)
Toxicity between two arms
8-9 years
Study Arms (2)
FLAG
OTHERFLAG and LP Dox
OTHERInterventions
See Detailed Description section for details of treatment interventions.
See Detailed Description section for details of treatment interventions.
See Detailed Description section for details of treatment interventions.
See Detailed Description section for details of treatment interventions.
Eligibility Criteria
You may qualify if:
- Children and adolescents less than eighteen years of age at start of chemotherapy.
- Subject has one of the following: Primary refractory AML, first relapsed AML, second or subsequent relapsed AML and was not previously treated according to this particular protocol
- Subjects with a combined relapse, or an isolated extramedullary relapse, or a bone marrow relapse are eligible, also for randomization.
You may not qualify if:
- Symptomatic cardiac dysfunction.
- Inadequate performance score.
- Any other organ dysfunction that will interfere with the administration of the therapy.
- FAB type M3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dutch Childhood Oncology Grouplead
- International BFM Study Groupcollaborator
- St. Jude Children's Research Hospitalcollaborator
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Kaspers J, Zimmermann M, Fleischhack G, Tamminga R, Gibson B, Armendariz H, Dworzak M, Ha S, Hovi L, Maschan A, Philippe N, Razzouk B, Rizzari C, Smisek P, Smith O, Stark B, Will A, Creutzig U. Relapsed Acute Myeloid Leukemia in Children and Adolescents: Interim Report of the International Randomised Phase III Study Relapsed AML 2001/01. 2006 ASH Annual Meeting Abstracts 108: 2013.
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Rubnitz, M.D.
St. Jude Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
March 1, 2002
Primary Completion
April 1, 2009
Study Completion
September 1, 2010
Last Updated
April 6, 2011
Record last verified: 2011-04