CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled
Drug / intervention
Decitabine +4 moredrug
Likely dose
Decitabine 5 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03263936
NCT03263936Phase 1Completed
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Epigenetic Reprogramming in Relapse AML: A Phase 1 Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults With Relapsed/Refractory AML

Therapeutic Advances in Childhood Leukemia Consortium·interventional·Posted Aug 28, 2017·Updated Oct 16, 2025

In Brief

A Phase 1 clinical trial evaluating Decitabine, Vorinostat, and 3 other interventions for Acute Myelogenous Leukemia. Completed, enrolled 37 participants across 33 sites in 3 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 28, 2017
Enrollment StartJul 11, 2017
Primary CompletionJul 9, 2020
Study CompletionFeb 10, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.8 years ago

Interventions

Decitabinedrug

Dose Level #0: 5 mg/m2 Dose Level #1: 7.5 mg/m2 Dose Level #2: 10 mg/m2 Dose Level #3: 15 mg/m2 Dose Level #4: 20 mg/m2 given IV over \_\_ hour on days 1 through 5

Vorinostatdrug

Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.

Filgrastim (G-CSF)drug

Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)

Fludarabinedrug

30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)

Cytarabinedrug

2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10