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Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT00111345
Recruitment Status : Unknown
Verified March 2012 by University Hospital Muenster.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2005
Last Update Posted : May 23, 2012
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:

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 or disease Intervention/treatment Phase
Myeloid Leukemia Drug: Anthracyclines Drug: liposomal daunorubicin Drug: 2-CDA Drug: AI Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
  2. Concerning objective 3: Disease-free survival from the date of randomisation [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Cardiotoxicity [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111345

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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)
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Principal Investigator: Ursula Creutzig, Prof. Dr. med. Medical School Hannover
Principal Investigator: Dirk Reinhardt, Prof. Dr. med. Medical School Hanover
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00111345    
Obsolete Identifiers: NCT00478153
Other Study ID Numbers: BfArM 4022064
DKH 50-2728
First Posted: May 20, 2005    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: March 2012
Keywords provided by University Hospital Muenster:
Acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs