Epigenetic Reprogramming in Relapse/Refractory AML
1 other identifier
interventional
37
3 countries
33
Brief Summary
This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2017
Longer than P75 for phase_1
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedResults Posted
Study results publicly available
October 16, 2025
CompletedOctober 16, 2025
May 1, 2023
3 years
August 21, 2017
May 26, 2023
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Dose of Decitabine That Can be Safely Given With Vorinostat, Fludarabine, High Dose Cytarabine and G-CSF (FLAG)
The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy
during course 1 DLT evaluation period, approx 9 weeks
Study Arms (1)
Other
OTHERdecitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Interventions
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
Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
Eligibility Criteria
You may qualify if:
- \- Patients must be ≥ 1 and ≤25 years of age.
- Diagnosis: Patients with relapse or refractory AML must have measurable disease ( \>M1 marrow)
- st or greater relapse, OR
- Failed to go into remission after 1st or greater relapse, OR
- Failed to go into remission from original diagnosis after 2 or more induction attempts
- Eligibility for patients with an M1 marrow; defined as \>0.1% by flow or molecular testing (e.g. PCR).
- must include two serial marrows (at least 1-week apart) demonstrating stable or rising minimal residual disease (MRD) (i.e. not declining).
- Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy.
- Patients with secondary AML are eligible.
- Patients with Down syndrome are eligible.
- Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.
- Performance Level:
- \- Karnofsky \>50% for patients \>16 years of age and Lansky \> 50% for patients ≤ 16 years of age (See Appendix II for Performance Scales)
- Prior therapy - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Cytoreduction with hydroxyurea: hydroxyurea can be initiated and continued for up to 24 hours prior to the start of decitabine/vorinostat. It is recommended to use hydroxyurea in patients with significant leukocytosis (WBC \>50,000/L) to control blast count before initiation of systemic protocol therapy.
- +18 more criteria
You may not qualify if:
- No NG or G-Tube administration of Vorinostat is allowed. Capsule must be swallowed whole or given as oral suspension.
- They are currently receiving other investigational drugs.
- There is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
- They have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- They have a known allergy to any of the drugs used in the study.
- Patients with DNA fragility syndromes are excluded (e.g. Fanconi Anemia, Bloom Syndrome)
- They are receiving valproic acid (VPA) therapy.
- Patients with Acute Promyelocytic Leukemia (APL, APML) are excluded
- Patients with documented active and uncontrolled infection at the time of study entry are not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Orange County
Orange, California, 92868, United States
UCSF School of Medicine
San Francisco, California, 94158, United States
The Children's Hospital, University of Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Miami
Miami, Florida, 33136, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
National Cancer Institute, Pediatric Oncology Branch
Bethesda, Maryland, 20892, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914, United States
CS Mott Children's Hospital, Ann Arbor
Ann Arbor, Michigan, 48109, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
New York University Medical Center
New York, New York, 10016, United States
Children's Hospital New York-Presbyterian
New York, New York, 10032, United States
Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Cancer Center, Baylor
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Children's Hospital at Westmead
Westmead, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Sainte Justine University Hospital
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ellynore Florendo
- Organization
- Therapeutic Advanced in Childhood Leukemia and Lymphoma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 28, 2017
Study Start
July 11, 2017
Primary Completion
July 9, 2020
Study Completion
February 10, 2022
Last Updated
October 16, 2025
Results First Posted
October 16, 2025
Record last verified: 2023-05