Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
50 Years
70 Years
Both
Acute Myeloid Leukemia
Trial Information
Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
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 received a failing course of remedial Mitoxantrone involving x 2 and j ARAC
1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with,
according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st
treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then
randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no
treatment.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
Authority:
France: Ministry of Health
Study ID:
ALFA 9801
NCT ID:
NCT00931138
Start Date:
December 1999
Completion Date:
December 2006
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia in adults
- Newly-diagnosed untreated AML
- Patient aged 50 to 70 years
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|
