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Brief Title: AC220 for Children With Relapsed/Refractory ALL or AML
Official Title: A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML
Study ID: NCT01411267
Brief Summary: This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).
Detailed Description: This is a study for pediatric patients with relapsed acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). Some people diagnosed with leukemia have changes in a receptor located on the surface of white blood cells called FLT3. This is known as a FLT3 mutation. FLT3 plays an important role in the way cells grow and divide. In normal cells, the FLT3 receptor is switched off most of the time and only switches on when it gets a chemical signal from outside. But cells with the FLT3 mutation have the grow signal permanently switched on. This means leukemia cells with the FLT3 mutation are growing and dividing all the time. Doctors have found that people with leukemia cells that carry FLT3 mutations are less likely to go into remission with chemotherapy and have a higher risk of the leukemia coming back after treatment. This is a study of an investigational drug called AC220. AC220 is considered investigational because it has not been approved in the United States by the Food and Drug Administration (FDA). AC220 is a drug which is able to "turn off" the FLT3 grow signal. AC220 will be given with cytarabine and etoposide to treat the relapsed leukemia. This is a phase I study, which means that the study is being done to find the highest dose of AC220 that can be given safely with the drugs cytarabine and etoposide to children and young adults.
Minimum Age: 1 Month
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Childrens Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Central California, Madera, 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 Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber, Boston, Massachusetts, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
Seattle Children's Hospital, Seattle, Washington, United States
Name: Todd Cooper, MD
Affiliation: Children's Healthcare of Atlanta, Emory University
Role: STUDY_CHAIR