A phase II study of dexamethasone added to induction and post-remission therapy in older patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study.

A phase II study of dexamethasone added to induction and post-remission therapy in older patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study. - DEXAML-02

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004860-36-FR

Enrollment

120

Registered

2018-03-20

Start date

2018-05-15

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients > 60 years with untreated acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10000835 Term: Acute leukemia System Organ Class: 100000004864

Interventions

Trade Name: DEXAMETHASONE Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 MRC 2010 classification 4. Subjects should be eligible for intensive chemotherapy by Idarubicine, cytarabine, Lomustine. 5. ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether adding dexamethasone to ICL induction and IC post-remission therapy results in significant improvement of event-free survival (EFS) in patients >60 years with newly diagnosed AML as compared with a historical cohort of the FILO LAM-SA 2007 trial.;Secondary Objective: To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on response to therapy, presence of minimal residual disease (MRD), allogeneic stem-cell transplantation, relapse from complete remission (CR) or CR with incomplete hematologic recovery (CRi), relapse-free survival (RFS), overall survival (OS), in patients >60 years with newly diagnosed AML. To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on EFS, response to therapy, relapse from CR or CRi, OS, according to AML heterogeneity and post-remission therapy. AML heterogeneity includes leukocytosis (white blood cells (WBC) =30 G/L versus <30 G/L), molecular subgroups (NPM1, FLT3-ITD, RUNX1, DNMT3A mutations), and cytogenetic subgroups (favorable, intermediate and adverse). Post-remission therapy includes allogeneic stem cell transplantation. To assess the safety of adding dexamethasone to ICL induction and IC post-remission therapy.;Primary end point(s): The primary endpoint is the EFS defined as the time from the date of inclusion 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 2017 European Leukemia Net (ELN) recommendations. ;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To determine whether adding dexamethasone to ICL induction and IC post-remission therapy results in significant improvement of event-free survival (EFS) in patients >60 years with newly diagnosed AML as compared with a historical cohort of the FILO LAM-SA 2007 trial.;Secondary Objective: To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on response to therapy, presence of minimal residual disease (MRD), allogeneic stem-cell transplantation, relapse from complete remission (CR) or CR with incomplete hematologic recovery (CRi), relapse-free survival (RFS), overall survival (OS), in patients >60 years with newly diagnosed AML. To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on EFS, response to therapy, relapse from CR or CRi, OS, according to AML heterogeneity and post-remission therapy. AML heterogeneity includes leukocytosis (white blood cells (WBC) =30 G/L versus <30 G/L), molecular subgroups (NPM1, FLT3-ITD, RUNX1, DNMT3A mutations), and cytogenetic subgroups (favorable, intermediate and adverse). Post-remission therapy includes allogeneic stem cell transplantation. To assess the safety of adding dexamethasone to ICL induction and IC post-remission therapy.;Primary end point(s): The primary endpoint is the EFS defined as the time from the date of inclusion 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 2017 European Leukemia Net (ELN) recommendations. ;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): Response to therapy after induction therapy defined as CR according to the 2017 ELN recommendations. Response to therapy after induction therapy defined as CR or CRi according to the 2017 ELN recommendations. Presence of MRD after induction therapy and after post-remission therapy, measured by either quantitative PCR or flow cytometry. Allogeneic stem cell transplantation during post-remission therapy course. Remission duration (relapse from CR or CRi) defined as the time from the date of CR or CRi to the date of relapse according to the 2017 ELN recommendations. RFS defined as the time from the date of CR or CRi to the date of relapse or death from any cause, whichever occurs first, according to the 2017 ELN recommendations. Overall survival defined as the time from the date of randomization to the date of death from any cause. Adverse events reported according to the descriptions and grading scale found in the version 4.0 of the NCI-CTCAE.;Timepoint(s) of evaluation of this end point: 80 months	—

Measure

Time frame

Secondary end point(s): Response to therapy after induction therapy defined as CR according to the 2017 ELN recommendations. Response to therapy after induction therapy defined as CR or CRi according to the 2017 ELN recommendations. Presence of MRD after induction therapy and after post-remission therapy, measured by either quantitative PCR or flow cytometry. Allogeneic stem cell transplantation during post-remission therapy course. Remission duration (relapse from CR or CRi) defined as the time from the date of CR or CRi to the date of relapse according to the 2017 ELN recommendations. RFS defined as the time from the date of CR or CRi to the date of relapse or death from any cause, whichever occurs first, according to the 2017 ELN recommendations. Overall survival defined as the time from the date of randomization to the date of death from any cause. Adverse events reported according to the descriptions and grading scale found in the version 4.0 of the NCI-CTCAE.;Timepoint(s) of evaluation of this end point: 80 months

—

Countries

France

Contacts

Public ContactFILO study central office

FILO

filo@univ-tours.fr33247 39 18 96

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026