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Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by University Hospital Muenster.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University Hospital Muenster
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00111345
First received: May 19, 2005
Last updated: May 21, 2012
Last verified: March 2012
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Purpose
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.
The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
| Condition | Intervention | Phase |
|---|---|---|
| Myeloid Leukemia | Drug: Anthracyclines Drug: liposomal daunorubicin Drug: 2-CDA Drug: AI | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2 [ Time Frame: 5 years ]
- Concerning objective 3: Disease-free survival from the date of randomisation [ Time Frame: 5 years ]
Secondary Outcome Measures:
- Cardiotoxicity [ Time Frame: 5 years ]
| Enrollment: | 550 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | March 2017 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Daunoxome, standard risk
|
Drug: liposomal daunorubicin
3x80 mg/qm
Other Name: Daunoxome
|
|
Active Comparator: 2
Idarubicin, standard risk
|
Drug: Anthracyclines
3x12 mg/qm
Other Name: Idarubicin
|
|
Experimental: 3
Daunoxome, high-risk, 2-CDA
|
Drug: 2-CDA
2x6 mg/qm
Other Name: Cladribine
|
|
Active Comparator: 4
Idarubicin, high-risk, nothing
|
Drug: AI
AI
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age from >0 to </=18 years
- De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
- Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Exclusion Criteria:
- Children with pre-existing syndromes (except Down syndrome)
- AML as secondary malignancy
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00111345
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111345
Locations
| Germany | |
| University Children's Hospital Muenster, Department of Paediatric Haematology and Oncology | |
| Muenster, North Rhine-Westphalia, Germany, D-48129 | |
Sponsors and Collaborators
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
| Principal Investigator: | Ursula Creutzig, Prof. Dr. med. | Medical School Hannover |
| Principal Investigator: | Dirk Reinhardt, Prof. Dr. med. | Medical School Hanover |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00111345 History of Changes |
| Obsolete Identifiers: | NCT00478153 |
| Other Study ID Numbers: |
BfArM 4022064 DKH 50-2728 |
| Study First Received: | May 19, 2005 |
| Last Updated: | May 21, 2012 |
Keywords provided by University Hospital Muenster:
|
Acute myeloid leukemia Acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Daunorubicin Idarubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 21, 2017