Register AML-BFM 2017 for the registration of acute myelogenous leukemia in children and adolescents
Organizational Data
- DRKS-ID:
- DRKS00013030
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2018-02-26
- Last update in DRKS:
- 2021-03-08
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Register AML-BFM 2017
URL of the study
https://www.aml-bfm.de/studienuebersicht/register-aml-bfm-2017/
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.
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.
Health condition or problem studied
- Free text:
- Acute myelogenous leukemia
- ICD10:
- C92.0 - Acute myeloblastic leukaemia [AML]
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Data Registration of all childhood AML-cases
Endpoints
- Primary outcome:
- 1. Registration of all AML diseases and their treatment in children and adolescents in the participating centers of all participating countries
- 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
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Czechia
- Germany
- Slovakia
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Alle G-BA- zertifizierten kinderonkologischen Zentren in Deutschland; ausgewählte Zentren in Österreich, Tschechien, der Schweiz und der Slowakei
Recruitment period and number of participants
- Planned study start date:
- 2017-10-01
- Actual study start date:
- 2017-12-13
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 0 Years
- Maximum Age:
- 18 Years
- 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
Exclusion Criteria
• Missing Informed Consent Forms oft he patient and/or his/her legal representative
Addresses
Primary Sponsor
- Address:
- GPOH gemeinnützige GmbH,AML-BFM StudienzentraleKatharina Waack-BuchholzHolsterhauser Platz 245147 EssenGermany
- Telephone:
- +49(0) 201 74949611
- Fax:
- +49(0) 201 8777 5484
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- AML-BFM studiengruppe, Universitätskinderklinik IIIProf. Dr.med. Reinhardt DirkHufelandstr. 5547122 EssenGermany
- Telephone:
- +49(0)201 723 3755
- Fax:
- +49(0)201 723 5386
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- AML-BFM studiengruppe, Universitätskinderklinik IIIProf. Dr.med. Reinhardt DirkHufelandstr. 5547122 EssenGermany
- Telephone:
- +49(0)201 723 3755
- Fax:
- +49(0)201 723 5386
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- AML-BFM studiengruppe, Universitätskinderklinik IIIProf. Dr.med. Reinhardt DirkHufelandstr. 5547122 EssenGermany
- Telephone:
- +49(0)201 723 3755
- Fax:
- +49(0)201 723 5386
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- GPOH gemeinnützige GmbH, AML-BFM StudienzentraleHolsterhauser Platz 245147 EssenGermany
- Telephone:
- +49(0) 201 74949611
- Fax:
- +49(0) 201 8777 5484
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-EssenRobert-Koch-Str. 9-1145147 EssenGermany
- Telephone:
- +49-201-7233637
- Fax:
- +49-201-7235837
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-03-20
- Ethics committee number:
- 17-7462-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-05-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry