Status:
COMPLETED
Treatment Outcome in Elderly Patients
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
French Innovative Leukemia Organisation
BGMT
Conditions:
AML
Elderly Patients
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL re...
Detailed Description
* Induction Therapy: * Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1 * if CR or PR: randomisation = maintenance therapy including or not androgens * Maintenance the...
Eligibility Criteria
Inclusion
- Patients aged 60 years or more
- "de novo" AML according to FAB criteria
- AML with 20% or more myeloid marrow blasts
- signed and dated informed consent
- OMS score \< 3
- Life expectancy \> 1 month
Exclusion
- Patients aged \< 60 years
- or AML M3
- or not classificated according to FAB criteria
- or extramedular localisation of AML
- OMS score ≥ 3
- clinical Abnormal Cardiac fonction or with left ejection fraction \< 40 %
- abnormal renal function with creatinine clearance \< 50/ml/mn/m²
- abnormal hepatic function
- previous cerebral stroke
- previous malignancy : prostate, breast cancer (males)
- PSA dosage \> 4
- Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00700544
Start Date
June 1 2002
End Date
May 1 2008
Last Update
June 18 2008
Active Locations (1)
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1
Arnaud PIGNEUX
Pessac, France, 33604