Clinical trial · Interventional
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
Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
NCT00931138CI-TRIAL-00002425ALFA 9801completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy (Aracytine + Daunorubicin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm1 = Aracytine + Daunorubicin
- description
- Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
- interventionNames
- Drug: chemotherapy (Aracytine + Daunorubicin)
- type
- ACTIVE_COMPARATOR
- label
- Arm 3 = Aracytine And Idarubicin
- description
- Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
- interventionNames
- Drug: chemotherapy (Aracytine + Daunorubicin)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 = Aracytine And Idarubicin
- description
- Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDSarkozy 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 23749683
- DERIVEDGardin 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 23248249
- DERIVEDItzykson 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 21459791
- DERIVEDBoissel 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 20625116