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Efficacy of G-CSF-Priming in Elderly AML Patients

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00199147
Collaborator
(none)
250
Enrollment
1
Location

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Jan 1, 2000

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
61 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Medical Department II Frankfurt Germany 60590

Sponsors and Collaborators

  • Johann Wolfgang Goethe University Hospital

Investigators

  • Study Chair: Oliver G Ottmann, MD, University Hospital, Medical Department II, Frankfurt, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00199147
Other Study ID Numbers:
  • AML-elderly 01/99 Trial
First Posted:
Sep 20, 2005
Last Update Posted:
Oct 26, 2005
Last Verified:
Sep 1, 2005
Additional relevant MeSH terms:
Leukemia
Cytarabine
Fludarabine
Etoposide
Idarubicin

Study Results

No Results Posted as of Oct 26, 2005