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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hannover Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Ulm
Johann Wolfgang Goethe University Hospitals
University Hospital Freiburg
Zentralklinikum, 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
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00209833
First received: September 13, 2005
Last updated: November 17, 2005
Last verified: September 2005
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


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
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: NCT00209833

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
University of Ulm
Johann Wolfgang Goethe University Hospitals
University Hospital Freiburg
Zentralklinikum, 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:
No publications provided by Hannover Medical School

Additional 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
Study First Received: September 13, 2005
Last Updated: November 17, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anemia
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine monophosphate
Fludarabine
Etoposide
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 24, 2014