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
Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
1 other identifier
interventional
420
1 country
16
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 1999
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedJuly 2, 2009
August 1, 1999
June 29, 2009
June 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
Frequency and severity of adverse events
Study Arms (3)
Arm1 = Aracytine + Daunorubicin
ACTIVE COMPARATORAracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Arm 3 = Aracytine And Idarubicin
ACTIVE COMPARATORAracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Arm 2 = Aracytine And Idarubicin
ACTIVE COMPARATORAracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Interventions
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
CH
Caen, 14033, France
Hopital Percy
Clamart, 92141, France
CHU
Créteil, 94010, France
CH
Lens, 62307, France
CHU
Lille, 59037, France
CH
Limoges, 87042, France
Hopital Edouard Herriot
Lyon, France
St Antoine Hospital
Paris, 75012, France
Hopital Pitie-Salpetriere
Paris, 75651, France
Hopital Saint-Louis
Paris, 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
Related Publications (4)
Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terre C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.
PMID: 23749683DERIVEDGardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terre C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.
PMID: 23248249DERIVEDItzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terre C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.
PMID: 21459791DERIVEDBoissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.
PMID: 20625116DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 2, 2009
Study Start
December 1, 1999
Study Completion
December 1, 2006
Last Updated
July 2, 2009
Record last verified: 1999-08