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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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