Efficacy of G-CSF-Priming in Elderly AML Patients
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
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedOctober 26, 2005
September 1, 2005
September 14, 2005
October 25, 2005
Conditions
Outcome Measures
Primary Outcomes (4)
-Remission rate after induction therapy
-Remission duration
-Disease free survival
-Overall survival
Secondary Outcomes (4)
-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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Medical Department II
Frankfurt, 60590, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Oliver G Ottmann, MD
University Hospital, Medical Department II, Frankfurt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 20, 2005
Study Start
January 1, 2000
Last Updated
October 26, 2005
Record last verified: 2005-09