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
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199147
First received: September 14, 2005
Last updated: October 25, 2005
Last verified: September 2005
  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
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
  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
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
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: 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 Hospitals
Investigators
Study Chair: Oliver G Ottmann, MD University Hospital, Medical Department II, Frankfurt, Germany
  More Information

No publications provided

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine phosphate
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
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on August 26, 2014