Status:
COMPLETED
Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2
Lead Sponsor:
Acute Leukemia French Association
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief Summary
Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2
Detailed Description
Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts r...
Eligibility Criteria
Inclusion
- Patient from 50 to 70 years
- AML de Novo
- No prior therapy for AML
- Absence of severe infection (WHO grade greater than 2), independent of the AML
- Cardiac function determined by radionucleotide or echography within normal limits.
- total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N
- ECOG performance status 0 to 3
- Signed informed consent.
Exclusion
- M3-AML
- history of neoplasia treated by radiotherapy or chemotherapy
- Myelodysplasia diagnosed more than 6 months before the diagnosis of AML
- Prior treatment for AML
- Uncontrolled infection
- Other active malignancy
- Patient unable to undergo regular surveillance
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00931138
Start Date
December 1 1999
End Date
December 1 2006
Last Update
July 2 2009
Active Locations (16)
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1
CH
Caen, France, 14033
2
Hopital Percy
Clamart, France, 92141
3
CHU
Créteil, France, 94010
4
CH
Lens, France, 62307