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Efficacy of G-CSF-Priming in Elderly AML Patients

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cytarabine
Etoposide
Idarubicin
G-CSF
Fludarabine
Stem cell apheresis
Stem cell transplantation
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Medical Department IIRecruiting

Outcomes

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

Full Information

First Posted
September 14, 2005
Last Updated
October 25, 2005
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00199147
Brief Title
Efficacy of G-CSF-Priming in Elderly AML Patients
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Type
Procedure
Intervention Name(s)
Stem cell apheresis
Intervention Type
Procedure
Intervention Name(s)
Stem cell transplantation
Primary Outcome Measure Information:
Title
-Remission rate after induction therapy
Title
-Remission duration
Title
-Disease free survival
Title
-Overall survival
Secondary Outcome Measure Information:
Title
-Toxicity according to WHO
Title
-Death in induction therapy
Title
-Feasibility to mobilize peripheral blood stem cells
Title
-Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver G Ottmann, MD
Organizational Affiliation
University Hospital, Medical Department II, Frankfurt, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Medical Department II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver G Ottmann, MD
Phone
++49-69-6301-4802
Email
ottmann@em.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Gesine Bug, MD
Phone
++49-69-6301-4802
Email
g.bug@em.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Oliver G Ottmann, MD
First Name & Middle Initial & Last Name & Degree
Gesine Bug, MD

12. IPD Sharing Statement

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Efficacy of G-CSF-Priming in Elderly AML Patients

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