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Efficacy of G-CSF-Priming in Elderly AML Patients

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. Identifier: NCT00199147
Recruitment Status : Unknown
Verified September 2005 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : October 26, 2005
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
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
Study Start Date : January 2000

Primary Outcome Measures :
  1. -Remission rate after induction therapy
  2. -Remission duration
  3. -Disease free survival
  4. -Overall survival

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

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

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

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 identifier (NCT number): NCT00199147

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University Hospital, Medical Department II Recruiting
Frankfurt, Germany, 60590
Contact: Oliver G Ottmann, MD    ++49-69-6301-4802   
Contact: Gesine Bug, MD    ++49-69-6301-4802   
Principal Investigator: Oliver G Ottmann, MD         
Sub-Investigator: Gesine Bug, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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Study Chair: Oliver G Ottmann, MD University Hospital, Medical Department II, Frankfurt, Germany

Layout table for additonal information Identifier: NCT00199147     History of Changes
Other Study ID Numbers: AML-elderly 01/99 Trial
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 26, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic