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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

Page last updated: August 23, 2015

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