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

Sponsor:	University Hospital Muenster
Collaborator:	Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00111345

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 II Phase III

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:

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Daunorubicin Daunorubicin hydrochloride Idarubicin hydrochloride Idarubicin Cladribine

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 ] [ 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 ]

Estimated Enrollment:	550
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	December 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111345

Contacts

Contact: Ursula Creutzig, Prof. Dr. med.	+49 (0)511-532-9123	aml-bfm@mh-hannover.de
Contact: Dirk Reinhardt, Prof. Dr. med.	+49 (0)511-532-9123	reinhardt.dirk@mh-hannover.de

Locations

Germany
University Children's Hospital Muenster, Department of Paediatric Haematology and Oncology	Recruiting
Muenster, North Rhine-Westphalia, Germany, D-48129
Contact: Ursula Creutzig, Prof. Dr. med. +49 (0)511-532-9123 aml-bfm@mh-hannover.de
Contact: Dirk Reinhardt, Prof. Dr. med. +49 (0)511-532-9123 reinhardt.dirk@mh-hannover.de
Principal Investigator: Ursula Creutzig, Prof. Dr. med.
Sub-Investigator: Dirk Reinhardt, Prof. Dr. med.

Sponsors and Collaborators

University Hospital Muenster

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

Principal Investigator:	Ursula Creutzig, Prof. Dr. med.	University Children's Hospital Muenster
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

No publications provided by University Hospital Muenster

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

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. Epub 2011 Apr 7.

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:	Prof. Dr. med. Ursula Creutzig, University Children's Hospital Münster
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:	June 10, 2010
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
2-chloro-3'-deoxyadenosine

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012