Efficacy of G-CSF-Priming in Elderly AML Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Cytarabine
* Drug: Etoposide
* Drug: Idarubicin
* Drug: G-CSF
* Drug: Fludarabine
* Procedure: Stem cell apheresis
* Procedure: Stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cytarabine|nan|
|Drug: Etoposide|nan|
|Drug: Idarubicin|nan|
|Drug: G-CSF|nan|
|Drug: Fludarabine|nan|
|Procedure: Stem cell apheresis|nan|
|Procedure: Stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Remission rate after induction therapy |  |  | 
| -Remission duration |  |  | 
| -Disease free survival |  |  | 
| -Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 |  |  |