Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years (AML2012)
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ClinicalTrials.gov Identifier: NCT01828489 |
Recruitment Status :
Recruiting
First Posted : April 10, 2013
Last Update Posted : January 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatric Acute Myeloblastic Leukemia | Drug: Randomisation course 1 mitoxantrone versus DaunoXome Drug: Randomisation course 2 ADxE versus FLADx | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | March 2018 |
Estimated Study Completion Date : | March 2023 |

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

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- AML as defined by the WHO diagnostic criteria
- Age < 19 years at time of diagnosis
- Written informed consent
Exclusion Criteria:
- Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
- AML secondary to previous bone marrow failure syndrome.
- Down syndrome (DS)
- Acute promyelocytic leukaemia (APL)
- Myelodysplastic syndrome (MDS)
- Juvenile Myelomonocytic Leukaemia (JMML)
- Known intolerance to any of the chemotherapeutic drugs in the protocol.
- Fanconi anaemia
- Major organ failure precluding administration of planned chemotherapy.
- Positive pregnancy test
- Lactating female or female of childbearing potential not using adequate contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828489
Contact: Jonas Abrahamsson, MD, PhD | +46 707695159 | jonas.abrahamsson@vgregion.se | |
Contact: Anna Schröder-Håkansson | anna.schroder-hakansson@vgregion.se |

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 |
Responsible Party: | Vastra Gotaland Region |
ClinicalTrials.gov Identifier: | NCT01828489 |
Other Study ID Numbers: |
NOPHO-DBH-AML2012 2012-002934-35 ( EudraCT Number ) |
First Posted: | April 10, 2013 Key Record Dates |
Last Update Posted: | January 10, 2017 |
Last Verified: | January 2017 |
Leukemia Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Mitoxantrone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |