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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
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Study Description
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Brief 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).

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Event-free survival [ Time Frame: 5 years ]
    Event-free survival at five years

  2. Acute toxicity [ Time Frame: six months ]
    Hematological and other organ toxicity after each course

  3. Long-term toxicity [ Time Frame: 10 years ]
    Long-term toxicity in particular cardiac toxicity

  4. Overall survival [ Time Frame: Five years ]
    Overall survival at five years


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jonas Abrahamsson, MD, PhD +46 707695159 jonas.abrahamsson@vgregion.se
Contact: Anna Schröder-Håkansson anna.schroder-hakansson@vgregion.se

Locations
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Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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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
More Information
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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
Additional relevant MeSH terms:
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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