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

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).

Conditions

• Pediatric Acute Myeloblastic Leukemia

Interventions

DRUG

Randomisation course 1 mitoxantrone versus DaunoXome

In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.

DRUG

Randomisation course 2 ADxE versus FLADx

The second course is randomised to either ADxE (standard arm) or FLADx

Sponsors & Collaborators

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Jonas Abrahamsson, MD, PhD · Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden

• Barbara de Moerloose, MD, PhD · Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology, 3K12D, De Pintelaan 185 - 9000 Gent, Belgium

• Ha Shau-Yin, MD, PhD · Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong

• Henrik Hasle, MD, PhD · Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark

• Kirsi Jahnukainen, MD, PhD · Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland

• Olafur G Jonsson, MD, PhD · Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland

• Gertjan Kaspers, MD, PhD · Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands

• Birgitte Lausen, MD, PhD · Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark

• Josefine Palle, MD, PhD · Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden

• Kadri Saks, MD, PhD · Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia.

• Bernward Zeller, MD, PhD · Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2018-03-31

Completion

2023-03-31

Countries

• Belgium
• Denmark
• Estonia
• Finland
• Hong Kong
• Iceland
• Netherlands
• Norway
• Sweden

Study Locations