Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Hannover Medical School University of Ulm Klinikum der J.W. Goethe Universitaet University Hospital Freiburg Zentralklinikum, Augsburg Humboldt-Universität zu Berlin Universitätsklinik Eppendorf University Hospital, Ghent Medizinische Universitätsklinik Tübingen Klinikum Hanover-Siloah Hospital Ev. Krankenhaus Essen-Werden Klinikum Wuppertal GmbH
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00209833

Purpose

This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.

Condition	Intervention	Phase
De Novo Akute Myeloid Leukemia (AML) Secondary Acute Myeloid Leukemia (AML) Refractory Anemia With Excess of Blasts in Transformation	Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: Fludarabine Drug: G-CSF Drug: Daunorubicine	Phase II Phase III

MedlinePlus related topics: Anemia Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Fludarabine Fludarabine monophosphate Granulocyte colony-stimulating factor Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.

Secondary Outcome Measures:

Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

Estimated Enrollment:	200
Study Start Date:	January 1999
Estimated Study Completion Date:	September 2005

Detailed Description:

Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.

Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)

Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR

Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
diagnosis of secondary AML after chemo-/radiotherapy or MDS
diagnosis of RAEB-T
age between 16 and 60 years (including 60 years)
women after exclusion of pregnancy
written informed consent

Exclusion Criteria:

patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
patients with DLCO < 50%
patients with creatinine clearance < 60 ml/min
patients with bilirubin > 2mg% (34.2 mmol/L)
patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
HIV positivity
patients with a t(15;17) translocation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209833

Locations

Germany
Hannover Medical School
Hannover, Germany, 30625

Sponsors and Collaborators

Hannover Medical School

University of Ulm

Klinikum der J.W. Goethe Universitaet

University Hospital Freiburg

Zentralklinikum, Augsburg

Humboldt-Universität zu Berlin

Universitätsklinik Eppendorf

University Hospital, Ghent

Medizinische Universitätsklinik Tübingen

Klinikum Hanover-Siloah Hospital

Ev. Krankenhaus Essen-Werden

Klinikum Wuppertal GmbH

Investigators

Principal Investigator:

Arnold Ganser, Prof. Dr.

Hannover Medical School

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	AML 01/99 trial
Study First Received:	September 13, 2005
Last Updated:	November 17, 2005
ClinicalTrials.gov Identifier:	NCT00209833
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Myelodysplastic syndromes
Refractory anemia
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Anemia
Acute myelogenous leukemia
Fludarabine monophosphate
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Etoposide phosphate

Leukemia
Idarubicin
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Fludarabine
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Etoposide
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009