A Phase 3 interventional study of chemotherapy (Aracytine + Daunorubicin) and chemotherapy (Aracytine + Daunorubicin) in Acute Myeloid Leukemia, sponsored by Acute Leukemia French Association. Completed at 16 sites in France. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-07-02.
Sponsored by Acute Leukemia French Association · Phase 3, Interventional, and Treatment
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
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 420 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Acute Leukemia French Association is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
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
Frequency and severity of adverse events
This study is completed, as verified in Aug 1999. You cannot join it, but the record below documents what was studied.
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Acute Leukemia French Association