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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Vastra Gotaland Region
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT01828489
First received: April 6, 2013
Last updated: January 23, 2014
Last verified: April 2013
  Purpose

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 Intervention Phase
Pediatric Acute Myeloblastic Leukemia
Drug: Randomisation course 1 mitoxantrone versus DaunoXome
Drug: Randomisation course 2 ADxE versus FLADx
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vastra Gotaland Region:

Primary Outcome Measures:
  • Minimal residual disease [ Time Frame: On day 22 after the first induction and after second induction ] [ Designated as safety issue: No ]
    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:
  • Event-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Event-free survival at five years

  • Acute toxicity [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Hematological and other organ toxicity after each course

  • Long-term toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Long-term toxicity in particular cardiac toxicity

  • Overall survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
    Overall survival at five years


Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828489

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

Locations
Belgium
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology Not yet recruiting
Ghent, Belgium, 9000
Contact: Barbara de Moerloose, MD, PhD       barbara.demoerloose@uzgent.be   
Denmark
Department of Pediatrics, Aarhus University Hospital Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Henrik Hasle, MD, PhD       hasle@dadlnet.dk   
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen Recruiting
Copenhagen, Denmark
Contact: Birgitte Lausen, MD, PhD       birgitte.lausen@rh.regionh.dk   
Estonia
Tallinn Children's Hospital, Dep. Hematology oncology Not yet recruiting
Tallinn, Estonia, 13419
Contact: Kadri Saks, MD, PhD       kadri.saks@lastehaigla.ee   
Finland
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Kirsi Jahnukainen, MD, PhD       kirsi.jahnukainen@ki.se   
Department of Pediatrics, Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Pekka Riikonen    +358 447172392    pekka.riikonen@kuh.fi   
Principal Investigator: Pekka Riikonen         
Department of Pediatrics, Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Merja Möttönen    +358 83155251    merja.mottonen@ppshp.fi   
Principal Investigator: Merja Möttönen         
Department of Pediatrics, Tampere University Central Hospital Recruiting
Tampere, Finland, 33521
Contact: Mikko Arola    +358 3 31164386    mikko.arola@pshp.fi   
Principal Investigator: Mikko Arola         
Department of Pediatrics, Turku University Central Hospital Recruiting
Turku, Finland, 20520
Contact: Minna Koskenvuo, MD, PhD    +358 50 3624430    minna.koskenvuo@utu.fi   
Principal Investigator: Minna Koskenvuo         
Hong Kong
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Shau-Yin Ha, MD, PhD       syha@hku.hk   
Iceland
Children´s Hospital, Landspitali University Hospital Not yet recruiting
Reykjavik, Iceland
Contact: Olafur Jonsson, MD, PhD       olafurgi@landspitali.is   
Netherlands
VU University Medical Center Department of Pediatric Oncology/Hematology Recruiting
Amsterdam, Netherlands, 1007
Contact: Gertjan Kaspers, MD, PhD       GJL.Kaspers@vumc.nl   
Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: Huib Caron, MD, PhD       h.n.caron@amc.uva.nl   
Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Eveline de Bont, MD, PhD       e.de.bont@bkk.umcg.nl   
University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog Not yet recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Dunja te Loo, MD, PhD       m.teloo@cukz.umcn.nl   
Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam Not yet recruiting
Rotterdam, Netherlands, 3000 CB
Contact: Marry van den Heuvel-Eibrink, MD, PhD       m.vandenheuvel@erasmusmc.nl   
Norway
Department of Pediatrics, Haukeland University Hospital, Bergen Recruiting
Bergen, Norway, 5021
Contact: Dorota , Wojcik    +47 55 97 50 00    dorota.malgorzata.wojcik@helse-bergen.no   
Principal Investigator: Dorota Wojcik         
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet Recruiting
Oslo, Norway, N-0424
Contact: Bernward Zeller, MD, PhD       bernward.zeller@ous-hf.no   
Department of Pediatrics, University Hospital of North Norway, Tromsoe Recruiting
Tromsoe, Norway, N-9038
Contact: Trond Flaegstad    +47 91507766    Trond.Flaegstad@unn.no   
Principal Investigator: Trond Flaegstad         
Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital Recruiting
Trondheim, Norway, N-7006
Contact: Svein Kolmannskog    +47 815 55 850    svein.kolmannskog@ntnu.no   
Principal Investigator: Svein Kolmannskog         
Sweden
Queen Silvias Childrens and Adolescents Hospital Recruiting
Gothenburg, Sweden, 41685
Contact: Jonas Abrahamsson, MD, PhD       jonas.abrahamsson@vgregion.se   
Principal Investigator: Jonas Abrahamsson         
Dept of Pediatrics, Linköpings University Hospital Recruiting
Linköping, Sweden, 58185
Contact: Mikael Behrendtz, MD, PhD         
Principal Investigator: Mikael Behrendtz         
Dept of Pediatrics, Skåne University Hospital Recruiting
Lund, Sweden, 22241
Contact: Cornelis Pronk, MD, PhD       kees-jan.pronk@med.lu.se   
Astrid Lindgrens Barnsjukhus, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Karin Belander-Strålin, MD       karin.belander-stralin@karolinska.se   
Dept of Pediatrics, Norrlands University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Ulrika Norén-Nyström, MD, PhD       Ulrika.norennystrom@pediatri.umu.se   
Dept of Pediatrics, Akademiska barnsjukhuset Recruiting
Uppsala, Sweden, 751 85
Contact: Josefine Palle, MD, PhD       josefine.palle@akademiska.se   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT01828489     History of Changes
Other Study ID Numbers: NOPHO-DBH-AML2012, 2012-002934-35
Study First Received: April 6, 2013
Last Updated: January 23, 2014
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Mitoxantrone
Daunorubicin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on September 16, 2014