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Pediatric Acute Myeloblastic LeukemiaPhase 3AML2012NCT01828489

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

A Phase 3 study testing Randomisation course 1 mitoxantrone versus DaunoXome and Randomisation course 2 ADxE versus FLADx in people with Pediatric Acute Myeloblastic Leukemia, run by Vastra Gotaland Region at 32 sites in 9 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Pediatric Acute Myeloblastic Leukemia
What is being tested?
Randomisation course 1 mitoxantrone versus DaunoXome and Randomisation course 2 ADxE versus FLADx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
32 sitesin 9 countries
Study dates
Mar 2013to Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • AML as defined by the WHO diagnostic criteria
  • Age < 19 years at time of diagnosis
  • Written informed consent

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

32 sites in 9 countries.

Jonas Abrahamsson, MD, PhD contact

+46 707695159

jonas.abrahamsson@vgregion.se

Anna Schröder-Håkansson contact

anna.schroder-hakansson@vgregion.se

32 sites in 9 countries

Belgium7 sites, 7 recruiting

  • HUDERF, L'Hôpital des Enfants Hématologie / Oncologie

    Brussels, 1020

    Laurence Dedeken, MD, PhD, +32 2 4773311, laurence.dedeken@huderf.be

    Recruiting

  • UZ Brussel, Pediatrische Hemato-Oncologie F930

    Brussels, 1090

    Jutte Van der Werff ten Bosch, MD, PhD, +32 2 4774111, JVDWerff@uzbrussel.be

    Recruiting

  • UCL, Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Sophie Dupont, MD, PhD, +32 2 7641111, sophie.dupont@uclouvain.be

    Recruiting

  • Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology

    Ghent, 9000

    Barbara de Moerloose, MD, PhD, barbara.demoerloose@uzgent.be

    Recruiting

  • UZ Leuven, Kinder Hemato-Oncologie

    Leuven, 3000

    Anne Uyttebroeck, MD, PhD, +32 16 33 22 11, anne.uyttebroeck@uzleuven.be

    Recruiting

  • CHR Citadelle

    Liège

    Marie-Françoise Dresse, MD, PhD, +32 42238980, marie.francoise.dresse@chrcitadelle.be

    Recruiting

  • CHC Espérance

    Montegnée

    Pierre Philippet, MD, PhD, +32 42249111, pierre.philippet@chc.be

    Recruiting

Other trials in Belgium

Sweden6 sites, 6 recruiting

  • Queen Silvias Childrens and Adolescents Hospital

    Gothenburg, 41685

    Jonas Abrahamsson, MD, PhD, jonas.abrahamsson@vgregion.se

    Jonas Abrahamsson

    Recruiting

  • Dept of Pediatrics, Linköpings University Hospital

    Linköping, 58185

    Mikael Behrendtz, MD, PhD

    Mikael Behrendtz

    Recruiting

  • Dept of Pediatrics, Skåne University Hospital

    Lund, 22241

    Cornelis Pronk, MD, PhD, kees-jan.pronk@med.lu.se

    Recruiting

  • Astrid Lindgrens Barnsjukhus, Karolinska University Hospital

    Stockholm, 17176

    Karin Belander-Strålin, MD, karin.belander-stralin@karolinska.se

    Recruiting

  • Dept of Pediatrics, Norrlands University Hospital

    Umeå, 90185

    Ulrika Norén-Nyström, MD, PhD, Ulrika.norennystrom@pediatri.umu.se

    Recruiting

  • Dept of Pediatrics, Akademiska barnsjukhuset

    Uppsala, 751 85

    Josefine Palle, MD, PhD, josefine.palle@akademiska.se

    Recruiting

Other trials in Sweden

Finland5 sites, 5 recruiting

  • Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital

    Helsinki, 00029

    Kirsi Jahnukainen, MD, PhD, kirsi.jahnukainen@ki.se

    Recruiting

  • Department of Pediatrics, Kuopio University Hospital

    Kuopio, 70211

    Pekka Riikonen, +358 447172392, pekka.riikonen@kuh.fi

    Pekka Riikonen

    Recruiting

  • Department of Pediatrics, Oulu University Hospital

    Oulu, 90029

    Merja Möttönen, +358 83155251, merja.mottonen@ppshp.fi

    Merja Möttönen

    Recruiting

  • Department of Pediatrics, Tampere University Central Hospital

    Tampere, 33521

    Mikko Arola, +358 3 31164386, mikko.arola@pshp.fi

    Mikko Arola

    Recruiting

  • Department of Pediatrics, Turku University Central Hospital

    Turku, 20520

    Minna Koskenvuo, MD, PhD, +358 50 3624430, minna.koskenvuo@utu.fi

    Minna Koskenvuo

    Recruiting

Other trials in Finland

Netherlands5 sites, 5 recruiting

  • VU University Medical Center Department of Pediatric Oncology/Hematology

    Amsterdam, 1007

    Gertjan Kaspers, MD, PhD, GJL.Kaspers@vumc.nl

    Recruiting

  • Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology

    Amsterdam, 1100 DD

    Huib Caron, MD, PhD, h.n.caron@amc.uva.nl

    Recruiting

  • Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen

    Groningen, 9700 RB

    Eveline de Bont, MD, PhD, e.de.bont@bkk.umcg.nl

    Recruiting

  • University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog

    Nijmegen, 6500 HB

    Dunja te Loo, MD, PhD, m.teloo@cukz.umcn.nl

    Recruiting

  • Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam

    Rotterdam, 3000 CB

    Marry van den Heuvel-Eibrink, MD, PhD, m.vandenheuvel@erasmusmc.nl

    Recruiting

Other trials in Netherlands

Norway4 sites, 4 recruiting

  • Department of Pediatrics, Haukeland University Hospital, Bergen

    Bergen, 5021

    Dorota, Wojcik, +47 55 97 50 00, dorota.malgorzata.wojcik@helse-bergen.no

    Dorota Wojcik

    Recruiting

  • Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet

    Oslo, N-0424

    Bernward Zeller, MD, PhD, bernward.zeller@ous-hf.no

    Recruiting

  • Department of Pediatrics, University Hospital of North Norway, Tromsoe

    Tromsø, N-9038

    Trond Flaegstad, +47 91507766, Trond.Flaegstad@unn.no

    Trond Flaegstad

    Recruiting

  • Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital

    Trondheim, N-7006

    Svein Kolmannskog, +47 815 55 850, svein.kolmannskog@ntnu.no

    Svein Kolmannskog

    Recruiting

Other trials in Norway

Denmark2 sites, 2 recruiting

  • Department of Pediatrics, Aarhus University Hospital Skejby

    Aarhus, 8200

    Henrik Hasle, MD, PhD, hasle@dadlnet.dk

    Recruiting

  • Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen

    Copenhagen

    Birgitte Lausen, MD, PhD, birgitte.lausen@rh.regionh.dk

    Recruiting

Other trials in Denmark

Estonia1 site, 1 recruiting

  • Tallinn Children's Hospital, Dep. Hematology oncology

    Tallinn, 13419

    Kadri Saks, MD, PhD, kadri.saks@lastehaigla.ee

    Not yet recruiting

Other trials in Estonia

Hong Kong1 site, 1 recruiting

  • Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong

    Hong Kong

    Shau-Yin Ha, MD, PhD, syha@hku.hk

    Recruiting

Other trials in Hong Kong

Iceland1 site, 1 recruiting

  • Children´s Hospital, Landspitali University Hospital

    Reykjavik

    Olafur Jonsson, MD, PhD, olafurgi@landspitali.is

    Not yet recruiting

Other trials in Iceland

About this study

Official title: 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).

Being tested
Randomisation course 1 mitoxantrone versus DaunoXome, Randomisation course 2 ADxE versus FLADx

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Randomisation course 1 mitoxantrone versus DaunoXomeDrug

    In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.

  • Randomisation course 2 ADxE versus FLADxDrug

    The second course is randomised to either ADxE (standard arm) or FLADx

Study groups in NCT01828489
Study groupRoleWhat they receive
Standard arm MEC and ADxEActive comparatorStandard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
Receives: Drug: Randomisation course 1 mitoxantrone versus DaunoXome; Drug: Randomisation course 2 ADxE versus FLADx
Experimental DxEC and standard ADxEExperimentalExperimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
Receives: Drug: Randomisation course 1 mitoxantrone versus DaunoXome
Standard arm MEC and experimental FLADxExperimentalExperimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
Receives: Drug: Randomisation course 2 ADxE versus FLADx
Experimental DxEC and experimental FLADxExperimentalExperimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
Receives: Drug: Randomisation course 1 mitoxantrone versus DaunoXome; Drug: Randomisation course 2 ADxE versus FLADx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimal residual disease

    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

    Measured: On day 22 after the first induction and after second induction

Secondary outcomes (4)

  1. Event-free survival

    Event-free survival at five years

    Measured: 5 years

  2. Acute toxicity

    Hematological and other organ toxicity after each course

    Measured: six months

  3. Long-term toxicity

    Long-term toxicity in particular cardiac toxicity

    Measured: 10 years

  4. Overall survival

    Overall survival at five years

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2018 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828489
Sponsor's protocol ID
NOPHO-DBH-AML2012
Other IDs
2012-002934-35
Acronym
AML2012
Status last verified
Jan 2017
First submitted
6 Apr 2013
Last updated
10 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Tierens A, Arad-Cohen N, Cheuk D, De Moerloose B, Fernandez Navarro JM, Hasle H, Jahnukainen K, Juul-Dam KL, Kaspers G, Kovalova Z, Lausen B, Noren-Nystrom U, Palle J, Pasauliene R, Jan Pronk C, Saks K, Zeller B, Abrahamsson J. Mitoxantrone Versus Liposomal Daunorubicin in Induction of Pediatric AML With Risk Stratification Based on Flow Cytometry Measurement of Residual Disease. J Clin Oncol. 2024 Jun 20;42(18):2174-2185. doi: 10.1200/JCO.23.01841. Epub 2024 Apr 11.

    PubMed 38603646

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Randomisation course 1 mitoxantrone versus DaunoXome and Randomisation course 2 ADxE versus FLADx in people with Pediatric Acute Myeloblastic Leukemia, run by Vastra Gotaland Region at 32 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Belgium, Sweden, Finland, Netherlands, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jonas Abrahamsson, MD, PhD (+46 707695159, jonas.abrahamsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal residual disease (time frame: On day 22 after the first induction and after second induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.

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