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

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ClinicalTrials.gov Identifier: NCT00209833
Recruitment Status : Unknown
Verified September 2005 by Hannover Medical School.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : November 18, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 2 Phase 3

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


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 1999
Estimated Study Completion Date : September 2005


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
  2. 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 :
  1. Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
  2. Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT00209833


Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
University of Ulm
Johann Wolfgang Goethe University Hospital
University Hospital Freiburg
Klinikum Augsburg
Humboldt-Universität zu Berlin
Universitätsklinikum Hamburg-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

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

ClinicalTrials.gov Identifier: NCT00209833     History of Changes
Other Study ID Numbers: AML 01/99 trial
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 18, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm Metastasis
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Fludarabine
Etoposide
Cytarabine
Idarubicin
Daunorubicin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents