Trial document





This trial has been registered retrospectively.
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  DRKS00013030

Trial Description

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Title


Register AML-BFM 2017 for the registration of acute myelogenous leukemia in children and adolescents

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Trial Acronym

Register AML-BFM 2017

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URL of the Trial

https://aml-bfm-zfp.heystlab.com/index.php?id=387

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Brief Summary in Lay Language

The register is intended to cover all diseases of children and adolescents with AML and their treatment as well as the cytogenetic, molecular genetic and epigenetic characteristics of AML in children and adolescents. The response to standardized therapy can also provide important knowledge for the characterization of AML.

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Brief Summary in Scientific Language

Therapy intensification in the consecutive studies AML-BFM 78 to -98 has led to an improvement in the prognosis for children with an AML. However, only about 60% of children and adolescents survived the disease in the long term.
In accordance with the results of other study groups, the preliminary results of the study AML-BFM 2004 (5-year survival> 70%, end of randomization 4/2010) show that additional therapy intensification is possible and can contribute to the further improvement of healing possibilities.
The comprehensive genetic and molecular genetic characterization of the AML as well as the determination of the minimal residual disease (MRD) is crucial for the further optimization of the survival chances.
The register is intended to cover all diseases of children and adolescents with AML and their treatment as well as the cytogenetic, molecular genetic and epigenetic characteristics of AML in children and adolescents. The response to standardized therapy can also provide important knowledge for the characterization of AML.
Furthermore, the frequency and kinetics of the molecular relapse should be recorded during and after the completion of the intensive chemotherapy so that the MRD load in peripheral blood is to be determined monthly.

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Organizational Data

  •   DRKS00013030
  •   2018/02/26
  •   [---]*
  •   yes
  •   Approved
  •   17-7462-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Acute myelogenous leukemia
  •   C92.0 -  Acute myeloblastic leukaemia [AML]
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Interventions/Observational Groups

  •   Data Registration of all childhood AML-cases
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Registration of all AML diseases and their treatment in children and adolescents in the participating centers of all participating countries

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Secondary Outcome

2. Registration of genetic, molecular genetic and epigenetic characteristics of AML in children and adolescents
3. Determination of minimal residual disease (MRD) via morphology, immunophenotyping and molecular genetic
4. Registration of the frequency and kinetic of a molecular relapse

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
  •   Czech Republic
  •   Slovakia
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/12/13
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   18   Years
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Additional Inclusion Criteria

• Age 0 - <18 years
• de novo AML, Myeloid sarcoma, Acute Mixed Lineage Leukemia/ bi-phenotypic Leukemia (dominant myeloid acc. to WHO 2008) or
• AML as secondary malignant tumor or
• Transient Leukemias and Myeloid Leukemia in Trisomy 21 or
• Relapsed/refractory AML in children and adolescents or
• “Special" cases of AML-associated diseases after consultation with and approval by the Register chair
• Admission to an accredited pediatric oncology center acc. to GBA resolution “Pediatric Oncology”
• Existence of all necessary Informed Consent Forms

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Exclusion Criteria

• Missing Informed Consent Forms oft he patient and/or his/her legal representative

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Addresses

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    • GPOH gemeinnützige GmbH,AML-BFM Studienzentrale
    • Ms.  Katharina  Waack-Buchholz 
    • Hufelandstraße 17
    • 45147  Essen
    • Germany
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    • AML-BFM studiengruppe, Universitätskinderklinik III
    • Mr.  Prof. Dr.med.  Reinhardt  Dirk 
    • Hufelandstr. 55
    • 47122  Essen
    • Germany
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    • AML-BFM studiengruppe, Universitätskinderklinik III
    • Mr.  Prof. Dr.med.  Reinhardt  Dirk 
    • Hufelandstr. 55
    • 47122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • GPOH gemeinnützige GmbH, AML-BFM Studienzentrale
    • Ms.  Katharina  Waack-Buchholz 
    • Hufelandstraße 17
    • 45147  Essen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.