Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years — AML2012  

Pediatric Acute Myeloblastic Leukemia Clinical Trial

Official title: NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Pediatric Acute Myeloblastic Leukemia

• NCT number: NCT01828489
• Study type: Interventional
• Source: Vastra Gotaland Region
• Contact: Jonas Abrahamsson, MD, PhD
• Phone: +46 707695159
• Email: jonas.abrahamsson@vgregion.se
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2013
• Completion date: March 2023