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

  • STATUS
    Not Recruiting
  • participants needed
    120
  • sponsor
    French Innovative Leukemia Organisation
Updated on 4 July 2021
cytarabine
ejection fraction
gilbert's syndrome
consolidation therapy
idarubicin

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.

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/m/day, IV over 15 minutes, D1 to D5; Cytarabine 100 mg/m/d, IV continuous 24h-infusion D1 to D7; Lomustine 200 mg/m/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/m, IV over 15 minutes, D1; Cytarabine 50 mg/m/12h, subcutaneous, D1 to D5; Dexamethasone 20 mg/d, IV over 30 minutes, D1.

Details
Condition Acute myeloid leukemia
Treatment Dexamethasone
Clinical Study IdentifierNCT03609060
SponsorFrench Innovative Leukemia Organisation
Last Modified on4 July 2021

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