Status:
COMPLETED
Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
Lead Sponsor:
Dutch Childhood Oncology Group
Collaborating Sponsors:
International BFM Study Group
St. Jude Children's Research Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 de...
Detailed Description
Secondary objectives of this trial are: * To determine the toxicity of liposomal daunorubicin when added to FLAG, in terms of mucosal toxicity, bone marrow aplasia, short- and long-term cardiotoxicit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Symptomatic cardiac dysfunction.
- Inadequate performance score.
- Any other organ dysfunction that will interfere with the administration of the therapy.
- FAB type M3
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00186966
Start Date
March 1 2002
End Date
September 1 2010
Last Update
April 6 2011
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105