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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3 concomitant to induction and post remission chemotherapy in elderly patients with AML Induction
CHU ANGERS - Maladies du sang
Angers, France
Event Free survival (EFS)
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
Time frame: Within 2 years after the start of the Treatement
Treatment response
Response to therapy after induction therapy defined as CR or CRi according to the 2017 European Leukemia Net (ELN) recommendations.
Time frame: Up to 45 day
Minimal Residual Disease (MRD)
Presence of MRD after induction therapy and after post-remission therapy, measured by either quantitative PCR or flow cytometry
Time frame: Up to day 45 after induction chemotherapy, second and last consolidation cycle.
Allogenic Stem Cells Transplantation (ASCT)
Number of patients with ASCT
Time frame: Up to one year
Remission duration (relapse from CR or CRi)
Time from the date of CR or CRi to the date of relapse according to the 2017 ELN recommendations
Time frame: two years
Relapse Free Survival (RFS)
Time from the date of CR or CRi to the date of relapse or death from any cause, whichever occurs first, according to the ELN 2017 recommendations
Time frame: two years
Overall Survival (OS)
Time from the date of randomization to the date of death from any cause
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Avignon, France
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Bayonne, France
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Béziers, France
CHU Brest - Hôpital Morvan - Hématologie Clinique
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Castelnau-le-Lez, France
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Clermont-Ferrand, France
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Grenoble, France
Institut Paoli-Calmettes - Hématologie 2
Marseille, France
...and 15 more locations
Time frame: two years
Adverse events
Incidence and severity of Adverse Events according to the descriptions and grading scale found in the National Cancer Institute - Common Terminology Criteria (NCI-CTC) criteria v4.03
Time frame: up to 60 months