Clinical trial · Observational
Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia
Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
- 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)
The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.
Conditions
Conditions (2)
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 Myeloblastic Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Aged Higher Than 60 Years Old | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Core study therapy
- description
- * idarubicin for both induction and consolidation courses * if Cr, two cycles of IDAC alone (1.5g/m2 per infusion every 12hours, on D1, 3 and 5 of each cycle)
Primary outcomes (1)
- measure
- cumulative incidence of failures
- timeFrame
- 9 months
- description
- failures include * resistant disease defined according to the IWG AML response criteria * hypoplastic marrow after D42 and absence of myeloidrecovery * early relapse up to 9 months from CR : Either AML relapse as in the IWG classification or MDS relapse
Secondary outcomes (4)
- measure
- response rate
- timeFrame
- 9 months
- measure
- relapse rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 60 years or more * With a morphologically proven diagnosis of AML according to WHO 2008 classification * Not previously treated for AML * Signed informed consent. Exclusion Criteria: * APL in the WHO classification. * Ph1-positive AML or prior Ph1-positive disease * AML evolving from a prior MPN in the WHO 2008 classification. * Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma * ECOG Performance Status Score \> 3 * Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC. * Severe uncontrolled infection at inclusion time. * Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable. * Absence of Health Care Insurance
References
Publications (1)
- DERIVEDGardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Ades L, Marolleau JP, Malfuson JV, Gastaud L, Raffoux E, Lambert J, Braun T, Thomas X, Chantepie S, Cluzeau T, de Botton S, Berthon C, Boissel N, Duployez N, Terre C, Peffault de Latour R, Michallet M, Celli-Lebras K, Preudhomme C, Dombret H. Added prognostic value of secondary AML-like gene mutations in ELN intermediate-risk older AML: ALFA-1200 study results. Blood Adv. 2020 May 12;4(9):1942-1949. doi: 10.1182/bloodadvances.2019001349. PMID 32380535