Epigenetic Reprogramming in Relapse/Refractory AML

Part of paid clinical trials in Los Angeles, California.

Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Study ID
NCT03263936
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myelogenous Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    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
  • Vorinostat — DRUG
    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)
  • Fludarabine — DRUG
    30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
  • Cytarabine — DRUG
    2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10

Study Details

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

Key Dates

Start date
Jul 11, 2017
Status verified
May 2023
Primary completion
Jul 9, 2020
Completion
Feb 10, 2022

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Other
    decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)

Primary Outcome Measure

The Dose of Decitabine That Can be Safely Given With Vorinostat, Fludarabine, High Dose Cytarabine and G-CSF (FLAG) [ Time Frame: during course 1 DLT evaluation period, approx 9 weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital Orange CountyOrangeCalifornia92868-
UCSF School of MedicineSan FranciscoCalifornia94158-
The Children's Hospital, University of ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
University of MiamiMiamiFlorida33136-
All Children's HospitalSt. PetersburgFlorida33701-
Children's Healthcare of Atlanta, Emory UniversityAtlantaGeorgia30322-
Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Johns Hopkins UniversityBaltimoreMaryland21231-
Sidney Kimmel Cancer Center at Johns HopkinsBaltimoreMaryland21231-
National Cancer Institute, Pediatric Oncology BranchBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C.S. Mott Children's HospitalAnn ArborMichigan48109-0914-
CS Mott Children's Hospital, Ann ArborAnn ArborMichigan48109-
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesota55404-
Children's Hospital New York-PresbyterianNew YorkNew York10032-
New York University Medical CenterNew YorkNew York10016-
Levine Children's HospitalCharlotteNorth Carolina28203-
Cincinnati Children's HospitalCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Cook Children's Medical CenterFort WorthTexas76104-
Texas Children's Cancer Center, BaylorHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84113-
Seattle Children's HospitalSeattleWashington98105-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Orange County· Orange, CAUCSF School of Medicine· San Francisco, CAThe Children's Hospital, University of Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCUniversity of Miami· Miami, FL

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