Spots Global Cancer Trial Database for Dexamethasone Added to Intensive Chemotherapy in Older Patients With Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Dexamethasone Added to Intensive Chemotherapy in Older Patients With Acute Myeloid Leukemia (AML)
Official Title: A Phase II Study of Dexamethasone Added to Induction and Post-remission Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Study ID: NCT03609060
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: Patients will receive dexamethasone in addition to induction and post-remission chemotherapy The principal objective of the study is to determine whether adding dexamethasone to induction and post-remission therapy results in significant improvement of event-free survival (EFS) as compared with an historical cohort of the FILO LAM-SA 2007 trial. Induction therapy: Idarabucin + Cyrarabine + Lomustine (ICL) + Dexamethasone. Idarubicin 8 mg/m²/day, IV over 15 minutes, D1 to D5; Cytarabine 100 mg/m²/d, IV continuous 24h-infusion D1 to D7; Lomustine 200 mg/m²/d, orally at D1; Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3. Post remission therapy: Idarabucin + Cyrarabine (IC) + Dexamethasone Idarubicin 8 mg/m², IV over 15 minutes, D1; Cytarabine 50 mg/m²/12h, subcutaneous, D1 to D5; Dexamethasone 20 mg/d, IV over 30 minutes, D1.
Keywords
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
CHU Brest - Hôpital Morvan - Hématologie Clinique, Brest, , France
CH de Béziers - Hématologie, Béziers, , 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
Contact Details
Name: Christian RECHER, MD PD
Affiliation: +33 5 31 15 63 55
Role: PRINCIPAL_INVESTIGATOR
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