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

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

History of Changes

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

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Daunorubicin

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

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:

Click here for more information about this study: Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hassler A, Bochennek K, Gilfert J, Perner C, Schöning S, Creutzig U, Reinhardt D, Lehrnbecher T. Infectious Complications in Children With Acute Myeloid Leukemia and Down Syndrome: Analysis of the Prospective Multicenter Trial AML-BFM 2004. Pediatr Blood Cancer. 2016 Jun;63(6):1070-4. doi: 10.1002/pbc.25917. Epub 2016 Jan 27.

Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, Graf N, Klingebiel T, Kremens B, Lehrnbecher T, von Neuhoff C, Ritter J, Sander A, Schrauder A, von Stackelberg A, Starý J, Reinhardt D. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004. Blood. 2013 Jul 4;122(1):37-43. doi: 10.1182/blood-2013-02-484097. Epub 2013 May 23.

Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, von Neuhoff C, Sander A, Schrauder A, von Stackelberg A, Ritter J, Starý J, Reinhardt D. CNS irradiation in pediatric acute myleoid leukemia: equal results by 12 or 18 Gy in studies AML-BFM98 and 2004. Pediatr Blood Cancer. 2011 Dec 1;57(6):986-92. doi: 10.1002/pbc.22955. Epub 2011 Apr 7.

Klusmann JH, Creutzig U, Zimmermann M, Dworzak M, Jorch N, Langebrake C, Pekrun A, Macakova-Reinhardt K, Reinhardt D. Treatment and prognostic impact of transient leukemia in neonates with Down syndrome. Blood. 2008 Mar 15;111(6):2991-8. doi: 10.1182/blood-2007-10-118810. Epub 2008 Jan 8.

Meyer LH, Queudeville M, Eckhoff SM, Creutzig U, Reinhardt D, Karawajew L, Ludwig WD, Stahnke K, Debatin KM. Intact apoptosis signaling in myeloid leukemia cells determines treatment outcome in childhood AML. Blood. 2008 Mar 1;111(5):2899-903. Epub 2007 Dec 14.


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 June 23, 2017

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