NCT03609060

Dexamethasone Added to Intensive Chemotherapy in Older Patients with Acute Myeloid Leukemia (AML)

A Phase II Study of Dexamethasone Added to Induction and Post-remission Therapy in Older Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2018-08-24
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2018-08-01
• Last updated: 2024-10-29

Locations

25 sites across 1 country: France