Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00186966

Run by

Dutch Childhood Oncology Group

People needed

394

Starts

2002-03-01

Expected to finish

2010-09-01

Last updated by the study team

2011-04-06

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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