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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
This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of demethylating agents and HDAC inhibitors in combination have been previously shown to have synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This study will ask the question as to whether or not the combination of decitabine and vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome in patients with relapsed or refractory acute myelogenous leukemia.
Age
1 - 25 years
Sex
ALL
Healthy Volunteers
No
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Orange County
Orange, California, United States
UCSF School of Medicine
San Francisco, California, United States
The Children's Hospital, University of Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Start Date
July 11, 2017
Primary Completion Date
July 9, 2020
Completion Date
February 10, 2022
Last Updated
October 16, 2025
37
ACTUAL participants
Decitabine
DRUG
Vorinostat
DRUG
Filgrastim (G-CSF)
DRUG
Fludarabine
DRUG
Cytarabine
DRUG
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
NCT06859424
NCT07254312
Data Source & Attribution
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