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Epigenetic Reprogramming in Relapse/Refractory AML

NCT03263936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-10-16

Study results available
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Summary

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

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Decitabine

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

DRUG

Vorinostat

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

DRUG

Filgrastim (G-CSF)

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

DRUG

Fludarabine

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

DRUG

Cytarabine

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

Sponsors & Collaborators

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2020-07-09
Completion
2022-02-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03263936 on ClinicalTrials.gov