Efficacy of G-CSF-Priming in Elderly AML Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
First received: September 14, 2005
Last updated: October 25, 2005
Last verified: September 2005
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Hospitals:

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

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00199147

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 Hospitals
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 
Study First Received: September 14, 2005
Last Updated: October 25, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2016