Dexamethasone: Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3 concomitant to induction and post remission chemotherapy in elderly patients with AML Induction
Study summary
Recent preclinical and clinical data strongly suggested that dexamethasone could improve the activity of intensive chemotherapy in AML. In this study, the FILO study group will assess the impact of adding dexamethasone to both induction and consolidation therapy in older AML patients with intermediate or favorable risk.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. \> 60 years of age.
2. Newly diagnosed AML according to the World Health Organization (WHO) 2016 either de novo AML or therapy-related AML (i.e AML arising after previous cytotoxic therapy or radiation)
3. AML with favorable or intermediate cytogenetic risk according to Medical Research Council (MRC 2010) classification.
4. Subjects should be eligible for intensive chemotherapy by Idarubicin, cytarabine, Lomustine.
5. Eastern Cooperative Oncology Group (ECOG) performance status \< 3 (appendix 1).
6. SORROR score ≤ 3 (appendix 2).
7. Adequate baseline organ function defined by the criteria below:
* Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) unless bilirubin rise is due to Gilbert's syndrome
* Alanine Aminotransferase (ALAT) and Aspartate Transaminase (ASAT) ≤ 3xULN
* creatinin clearance (Cockcroft-Gault) ≥ 30 ml/min
* Unless considered due to leukemic organ involvement
8. Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥50%
9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
10. Women will be menopausal to be enrolled
11. The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
12. Affiliated to the French Social Security (Health Insurance).
Exclusion Criteria:
1. Acute promyelocytic leukemia (APL) or acute megakaryocytic leukemia (AML-FAB M7).
2. AML with adverse cytogenetic risk according to the MRC 2010 classification.
3. AML arising from myelodysplastic syndromes, myeloproliferative disorders or chronic myelo-monocytic leukemia according to WHO classification (2016).
4. AML with Philadelphia chromosome or with BCR-ABL1.
5. Known active central nervous system leukemia
6. Previous anti-AML treatment other than hydroxyurea.
7. Cumulative anthracycline dose equivalent to ≥550 mg/m².
8. Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
9. Prior history of cancer unless controlled for at least 2 years and except for basal cell carcinoma, non-melanoma skin cancer and in situ cervical carcinoma.
10. Severe medical or mental condition precluding the administration of protocol treatments
11. Any sign of active uncontrolled disease including but not restricted to cardiac disease, infections, hepatitis.
12. Any severe chronic disease potentially interfering with the protocol including HIV infection, active hepatitis B or C.
13. Any severe conditions inducing contra-indications to dexamethasone including uncontrolled diabetes, infections, hypertension, stomach ulcer, mental illness, myasthenia or glaucoma.
14. Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent.
15. Known active HIV, Hepatitis B or C infection.
16. Pregnancy or breastfeeding.
17. Patients who are incapacitated, under wardship, legal guardianship, or under the protection of the courts.
18. Patients under State Medical Assistance (AME).
Primary outcome measure(s)
Event Free survival (EFS) — Within 2 years after the start of the Treatement Time from the date of induction start to the date of induction failure, relapse from CR or CRi, or death from any cause, whichever occurs first. CR, CRi, relapse from CR or CRi and induction failure are defined according to the ELN 2017 recommendations
Trial sites (25)
Facility
City
Region
Status
CHU ANGERS - Maladies du sang
Angers
France
Ch Avignon
Avignon
France
CH de la Côte Basque - Hématologie
Bayonne
France
CHRU JEAN MINJOZ - Hématologie
Besançon
France
CH de Béziers - Hématologie
Béziers
France
CHU Brest - Hôpital Morvan - Hématologie Clinique
Brest
France
Clinique du Parc - Hématologie
Castelnau-le-Lez
France
CHU Estaing - Hématologie Clinique Adulte
Clermont-Ferrand
France
CHU Grenoble - Hématologie Clinique
Grenoble
France
Institut Paoli-Calmettes - Hématologie 2
Marseille
France
CHR de Mercy - Hématologie
Metz
France
Hôpital Saint-Eloi - Hématologie Clinique
Montpellier
France
HOPITAL E. MULLER - Hématologie
Mulhouse
France
CHU HOTEL DIEU - Hématologie Clinique
Nantes
France
CHR ORLEANS - Hématologie
Orléans
France
HOPITAL COCHIN - Hématologie
Paris
France
CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique
Perpignan
France
Hôpital Haut Levêque- CFM -Hématologie Clinique Et Thérapie Cellulaire
Pessac
France
CHU La Milétrie - Hématologie Clinique
Poitiers
France
CHU Reims - Hôpital Robert Debré - Hématologie Clinique
Reims
France
CHU Pontchaillou - Hématologie
Rennes
France
CHU Hautepierre - Hématologie
Strasbourg
France
Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie
Toulouse
France
CHU Bretonneau - Centre Henri Kaplan - Hématologie et Thérapie Cellulaire
Tours
France
CHU Nancy - Hopitaux Brabois
Vandœuvre-lès-Nancy
France
More French Innovative Leukemia Organisation trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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