Dexamethasone in Refractory or First Relapsed Acute Myeloid Leukemia
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.
Timeline
- Start
- 2020-01-13
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Cytarabine | Small molecule | 1 g | Intravenous |
| Background | Cytarabine | Small molecule | 3 g | Intravenous |
| Background | amsacrine | Small molecule | 200 mg/m2 | Intravenous |