drugset / Trial / NCT01828489

Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

NCT01828489

Phase 3 Unknown 300 enrolled Vastra Gotaland Region
RandomizedFactorialOpen-labelTreatment

Summary

This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).

Timeline

Start
2013-03
Primary completion
2018-03
Completion
2023-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Daunorubicin Small molecule
Subject Etoposide Small molecule
Subject Fludarabine Small molecule
Subject Mitoxantrone Small molecule
Background Cytarabine Small molecule