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Dexamethasone in Refractory or First Relapsed Acute Myeloid Leukemia

NCT03765541 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-04-10

No results posted yet for this study

Summary

Recent preclinical and retrospective clinical data have suggested that dexamethasone might sensitize leukemic cells to chemotherapy-induced cell death and thus limit the risk of leukemic regrowth and relapse. Moreover, it has been experimentally shown that leukemic cells in acute myeloid leukemia patients who relapse become sensitive to glucocorticoids treatment highlighting a novel potential role for dexamethasone in relapsed or refractory acute myeloid leukemia (R/R).

This study was designed to determine whether adding dexamethasone to standard salvage therapy in the treatment of relapsed/refractory acute myeloid leukemia in adult patients (intensive chemotherapy amsacrine-cytarabine or azacitidine according to investigator's willingness) results in a significant improvement of the overall survival.

Conditions

Interventions

DRUG

Dexamethasone

In combination with intensive chemotherapy amsacrine-cytarabine: * Induction (1 cycle): 10 mg/12h from Day 1 to Day 3 of cycle (2 infusions/24h, slow IV \[10 minutes\]) * Consolidation (3 cycles): 10 mg/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV \[10 minutes\]) In combination with azacitidine: * Cycle 1: 20 mg/24h from Day 1 to Day 3 of cycle (1 infusion/24h, slow IV \[10 minutes\]). * Subsequent cycles: 20 mg/24h on Day 1 of each cycle (1 infusion/24h, slow IV \[10minutes\]).

DRUG

Amsacrine

* Induction (1 cycle): 200 mg/m2/24h from Day 1 to Day 3 of cycle (slow IV \[3 hours\]) * Consolidation (3 cycles): 200 mg/m2/24h on Day 1 of each cycle (slow IV \[3 hours\])

DRUG

Cytarabine

Patients \< 60 years of age: * Induction (1 cycle): 3 g/m2/12h from Day 1 to Day 4 of cycle (2 infusions/24h, slow IV \[2 hours\]) * Consolidation (3 cycles): 3 g/m2/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV \[2 hours\]) Note: If the investigators believe that there is an undue risk for the safety of a patient under 60 years of age with comorbidity in receiving a dose level of 3 g/m2/12h, the dose may be reduced to 1 g/m2/12h

DRUG

Azacitidine

75 mg/m2/24h from Day 1 to Day 7 of each cycle \[or from Day 1 to Day 5 and from Day 8 to Day 9 of each cycle\] (SC)

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christian RECHER, PhD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765541 on ClinicalTrials.gov