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
Information source: Acute Leukemia French Association
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myeloid Leukemia
Intervention: chemotherapy (Aracytine + Daunorubicin) (Drug); chemotherapy (Aracytine + Daunorubicin) (Drug); chemotherapy (Aracytine + Daunorubicin) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Acute Leukemia French Association
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
Clinical Details
Official title: Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Frequency and severity of adverse events
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 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.
Eligibility
Minimum age: 50 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
CH, Caen 14033, France
Hopital Percy, Clamart 92141, France
CHU, Creteil 94010, France
CH, Lens 62307, France
CHU, Lille 59037, France
CH, Limoges 87042, France
Hopital Edouard Herriot, Lyon, France
Hopital Pitie-Salpetriere, Paris 75651, France
Hopital Saint-Louis, Paris, France
St Antoine Hospital, Paris 75012, France
CH, Roubaix 59100, France
CHU, Rouen 76038, France
CNLCC, Saint-Cloud 92210, France
CH, Valenciennes 59322, France
CH, Versailles, France
IGR, Villejuif 94805, France
Additional Information
Starting date: December 1999
Last updated: June 30, 2009
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