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

January 9, 2017 updated by: Vastra Gotaland Region

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1020
        • Recruiting
        • HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
        • Contact:
      • Brussel, Belgium, 1090
        • Recruiting
        • UZ Brussel, Pediatrische Hemato-Oncologie F930
        • Contact:
      • Brussel, Belgium, 1200
        • Recruiting
        • UCL, Cliniques Universitaires Saint-Luc
        • Contact:
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven, Kinder Hemato-Oncologie
        • Contact:
      • Liège, Belgium
      • Montegnée, Belgium
        • Recruiting
        • CHC Espérance
        • Contact:
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Department of Pediatrics, Aarhus University Hospital Skejby
        • Contact:
      • Copenhagen, Denmark
        • Recruiting
        • Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
        • Contact:
  • Estonia
      • Tallinn, Estonia, 13419
        • Not yet recruiting
        • Tallinn Children's Hospital, Dep. Hematology oncology
        • Contact:
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital
        • Contact:
      • Kuopio, Finland, 70211
        • Recruiting
        • Department of Pediatrics, Kuopio University Hospital
        • Contact:
        • Principal Investigator:
          • Pekka Riikonen
      • Oulu, Finland, 90029
        • Recruiting
        • Department of Pediatrics, Oulu University Hospital
        • Contact:
        • Principal Investigator:
          • Merja Möttönen
      • Tampere, Finland, 33521
        • Recruiting
        • Department of Pediatrics, Tampere University Central Hospital
        • Contact:
        • Principal Investigator:
          • Mikko Arola
      • Turku, Finland, 20520
        • Recruiting
        • Department of Pediatrics, Turku University Central Hospital
        • Contact:
        • Principal Investigator:
          • Minna Koskenvuo
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong
        • Contact:
  • Iceland
      • Reykjavik, Iceland
        • Not yet recruiting
        • Children´s Hospital, Landspitali University Hospital
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1007
        • Recruiting
        • VU University Medical Center Department of Pediatric Oncology/Hematology
        • Contact:
      • Amsterdam, Netherlands, 1100 DD
        • Recruiting
        • Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology
        • Contact:
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen
        • Contact:
      • Nijmegen, Netherlands, 6500 HB
        • Recruiting
        • University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog
        • Contact:
      • Rotterdam, Netherlands, 3000 CB
        • Recruiting
        • Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam
        • Contact:
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • Department of Pediatrics, Haukeland University Hospital, Bergen
        • Contact:
        • Principal Investigator:
          • Dorota Wojcik
      • Oslo, Norway, N-0424
        • Recruiting
        • Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet
        • Contact:
      • Tromsoe, Norway, N-9038
        • Recruiting
        • Department of Pediatrics, University Hospital of North Norway, Tromsoe
        • Contact:
        • Principal Investigator:
          • Trond Flaegstad
      • Trondheim, Norway, N-7006
        • Recruiting
        • Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital
        • Contact:
        • Principal Investigator:
          • Svein Kolmannskog
  • Sweden
      • Gothenburg, Sweden, 41685
        • Recruiting
        • Queen Silvias Childrens and Adolescents Hospital
        • Contact:
        • Principal Investigator:
          • Jonas Abrahamsson
      • Linköping, Sweden, 58185
        • Recruiting
        • Dept of Pediatrics, Linköpings University Hospital
        • Contact:
          • Mikael Behrendtz, MD, PhD
        • Principal Investigator:
          • Mikael Behrendtz
      • Lund, Sweden, 22241
        • Recruiting
        • Dept of Pediatrics, Skåne University Hospital
        • Contact:
      • Stockholm, Sweden, 17176
      • Umeå, Sweden, 90185
      • Uppsala, Sweden, 751 85

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. AML as defined by the WHO diagnostic criteria
  2. Age < 19 years at time of diagnosis
  3. Written informed consent

Exclusion Criteria:

  1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
  2. AML secondary to previous bone marrow failure syndrome.
  3. Down syndrome (DS)
  4. Acute promyelocytic leukaemia (APL)
  5. Myelodysplastic syndrome (MDS)
  6. Juvenile Myelomonocytic Leukaemia (JMML)
  7. Known intolerance to any of the chemotherapeutic drugs in the protocol.
  8. Fanconi anaemia
  9. Major organ failure precluding administration of planned chemotherapy.
  10. Positive pregnancy test
  11. Lactating female or female of childbearing potential not using adequate contraception

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard arm MEC and ADxE
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
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
Experimental: Experimental DxEC and standard ADxE
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
Drug: Randomisation course 1 mitoxantrone versus DaunoXome
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Experimental: Standard arm MEC and experimental FLADx
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
Drug: Randomisation course 2 ADxE versus FLADx
The second course is randomised to either ADxE (standard arm) or FLADx
Experimental: Experimental DxEC and experimental FLADx
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease
Time Frame: On day 22 after the first induction and after second induction
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
On day 22 after the first induction and after second induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 5 years
Event-free survival at five years
5 years
Acute toxicity
Time Frame: six months
Hematological and other organ toxicity after each course
six months
Long-term toxicity
Time Frame: 10 years
Long-term toxicity in particular cardiac toxicity
10 years
Overall survival
Time Frame: Five years
Overall survival at five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Study Chair: Jonas Abrahamsson, MD, PhD, Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden
  • Principal Investigator: 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
  • Principal Investigator: Ha Shau-Yin, MD, PhD, Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong
  • Principal Investigator: Henrik Hasle, MD, PhD, Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark
  • Principal Investigator: Kirsi Jahnukainen, MD, PhD, Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland
  • Principal Investigator: Olafur G Jonsson, MD, PhD, Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland
  • Principal Investigator: Gertjan Kaspers, MD, PhD, Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands
  • Principal Investigator: Birgitte Lausen, MD, PhD, Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark
  • Principal Investigator: Josefine Palle, MD, PhD, Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden
  • Principal Investigator: Kadri Saks, MD, PhD, Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia.
  • Principal Investigator: Bernward Zeller, MD, PhD, Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 6, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOPHO-DBH-AML2012
  • 2012-002934-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Acute Myeloblastic Leukemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe