Suspended

AML2012NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

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What is being tested

Randomisation course 1 mitoxantrone versus DaunoXome

+ Randomisation course 2 ADxE versus FLADx

+ Randomisation course 1 mitoxantrone versus DaunoXome

Drug
Who is being recruted

Until 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorVastra Gotaland Region
Study ContactJonas Abrahamsson, MD, PhDMore contacts
Last updated: January 10, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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).

NCT01828489
Principal SponsorVastra Gotaland Region
Study ContactJonas Abrahamsson, MD, PhDMore contacts
Last updated: January 10, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
AML as defined by the WHO diagnostic criteria
Age < 19 years at time of diagnosis
Written informed consent
11 exclusion criteria prevent from participating
AML secondary to previous bone marrow failure syndrome
Acute promyelocytic leukaemia (APL)
Down syndrome (DS)
Fanconi anaemia
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two

Group II

Experimental
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two

Group III

Experimental
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two

Group IV

Experimental
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Recruiting

HUDERF, L'Hôpital des Enfants Hématologie / Oncologie

Brussels, BelgiumOpen HUDERF, L'Hôpital des Enfants Hématologie / Oncologie in Google Maps
Recruiting

UZ Brussel, Pediatrische Hemato-Oncologie F930

Brussels, Belgium
Recruiting

UCL, Cliniques Universitaires Saint-Luc

Brussels, Belgium
Recruiting

Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology

Ghent, Belgium
Suspended32 Study Centers