drugset
drugset / Trial / NCT03263936

Epigenetic Reprogramming in Relapse/Refractory AML

NCT03263936 ↗

Phase 1 Completed 37 enrolled Therapeutic Advances in Childhood Leukemia Consortium
NaSingle-groupOpen-labelTreatment

Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).

Timeline

Start
2017-07-11
Primary completion
2020-07-09
Completion
2022-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 5 mg/m2 Intravenous
Subject Decitabine Small molecule 7.5 mg/m2 Intravenous
Subject Decitabine Small molecule 10 mg/m2 Intravenous
Subject Decitabine Small molecule 15 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Background Cytarabine Small molecule 2000 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Vorinostat Small molecule 180 mg/m2 —
Background Vorinostat Small molecule 200 mg —
Background filgrastim Protein / enzyme biologic 5 ug/kg Intravenous

Indications

acute myeloid leukemia