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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dutch Childhood Oncology Group
• Collaborators: International BFM Study Group; St. Jude Children's Research Hospital
• Treatments: Busulfan; Cyclophosphamide; Cytarabine; Daunorubicin; Etoposide; Fludarabine; Melphalan; Thioguanine

Criteria

Inclusion Criteria:

• 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 Criteria:

• Symptomatic cardiac dysfunction.

• Inadequate performance score.

• Any other organ dysfunction that will interfere with the administration of the therapy.

• FAB type M3