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Efficacy of G-CSF-Priming in Elderly AML Patients

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 September 2005 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199147
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Cytarabine Drug: Etoposide Drug: Idarubicin Drug: G-CSF Drug: Fludarabine Procedure: Stem cell apheresis Procedure: Stem cell transplantation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • -Remission rate after induction therapy
  • -Remission duration
  • -Disease free survival
  • -Overall survival

Secondary Outcome Measures:
  • -Toxicity according to WHO
  • -Death in induction therapy
  • -Feasibility to mobilize peripheral blood stem cells
  • -Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients

Estimated Enrollment: 250
Study Start Date: January 2000
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or
  • Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or
  • Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or
  • Extramedullary AML (chloroma, “granulocytic sarcoma”)
  • Age greater than 60 years (not including 60 years)
  • ECOG performance status 0, 1, or 2
  • Written informed consent

Exclusion Criteria:

  • Patients with a t(15;17) translocation
  • Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
  • Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock.
  • Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
  • Significant renal dysfunction (creatinine clearance < 60/min/min)
  • Bilirubin > 2mg% (>34.2 mmol/l)
  • Patients with a clinically active second malignancy
  • Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study
  • HIV positivity
  • Known refractoriness to platelet transfusion, inability to adequately substitute blood products
  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): NCT00199147


Locations
Germany
University Hospital, Medical Department II Recruiting
Frankfurt, Germany, 60590
Contact: Oliver G Ottmann, MD    ++49-69-6301-4802    ottmann@em.uni-frankfurt.de   
Contact: Gesine Bug, MD    ++49-69-6301-4802    g.bug@em.uni-frankfurt.de   
Principal Investigator: Oliver G Ottmann, MD         
Sub-Investigator: Gesine Bug, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Oliver G Ottmann, MD University Hospital, Medical Department II, Frankfurt, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00199147     History of Changes
Other Study ID Numbers: AML-elderly 01/99 Trial
First Submitted: September 14, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Fludarabine
Etoposide
Cytarabine
Idarubicin
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
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic