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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 (ALFA 9801)

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ClinicalTrials.gov Identifier: NCT00931138
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Acute Leukemia French Association

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: chemotherapy (Aracytine + Daunorubicin) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 1999
Estimated Study Completion Date : December 2006


Arm Intervention/treatment
Active Comparator: Arm1 = Aracytine + Daunorubicin
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Active Comparator: Arm 3 = Aracytine And Idarubicin
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-d4
Active Comparator: Arm 2 = Aracytine And Idarubicin
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3



Primary Outcome Measures :
  1. 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 Measures :
  1. Frequency and severity of adverse events


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931138


Locations
France
CH
Caen, France, 14033
Hopital Percy
Clamart, France, 92141
CHU
Creteil, France, 94010
CH
Lens, France, 62307
CHU
Lille, France, 59037
CH
Limoges, France, 87042
Hopital Edouard Herriot
Lyon, France
St Antoine Hospital
Paris, France, 75012
Hopital Pitie-Salpetriere
Paris, France, 75651
Hopital Saint-Louis
Paris, France
CH
Roubaix, France, 59100
CHU
Rouen, France, 76038
CNLCC
Saint-Cloud, France, 92210
CH
Valenciennes, France, 59322
CH
Versailles, France
IGR
Villejuif, France, 94805
Sponsors and Collaborators
Acute Leukemia French Association
Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr Sylvie Castaigne - Pricipal Investigator, CHV A. MIGNOT
ClinicalTrials.gov Identifier: NCT00931138     History of Changes
Other Study ID Numbers: ALFA 9801
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: August 1999

Keywords provided by Acute Leukemia French Association:
Acute Myeloid Leukemia in adults
Newly-diagnosed untreated AML
Patient aged 50 to 70 years

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Idarubicin
Cytarabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs