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Brief Title: Epigenetic Reprogramming in Relapse/Refractory AML
Official Title: 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
Study ID: NCT03263936
Brief Summary: This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
Detailed Description: 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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
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, District of Columbia, United States
University of Miami, Miami, Florida, United States
All Children's Hospital, Saint 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
Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
National Cancer Institute, Pediatric Oncology Branch, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
CS Mott Children's Hospital, Ann Arbor, Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States
New York University Medical Center, New York, New York, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Texas Children's Cancer Center, Baylor, Houston, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Children's Hospital at Westmead, Westmead, , Australia
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Sainte Justine University Hospital, Montreal, Quebec, Canada