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Spots Global Cancer Trial Database for Epigenetic Reprogramming in Relapse/Refractory AML

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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