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

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
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:


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 ] [ Designated as safety issue: Yes ]
  • Concerning objective 3: Disease-free survival from the date of randomisation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiotoxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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
Other Name: AI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by University Hospital Muenster

Additional 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
Acute
myeloid
leukemia
Acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Idarubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014