A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML
This is a study for 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The dose of AC220 that can be given safely with etoposide and cytarabine.
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.
6 weeks
Yes
Todd Cooper, MD
Study Chair
Children's Healthcare of Atlanta, Emory University
United States: Food and Drug Administration
T2009-004
NCT01411267
August 2011
May 2013
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Children's Hospital Central California | Madera, California 93638-8762 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
City of Hope | Duarte, California 91010 |
New York University Medical Center | New York, New York 10016 |
Oregon Health and Science University | Portland, Oregon 97201 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Children's Mercy Hospitals and Clinics | Kansas City, Missouri 64108 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
Dana Farber | Boston, Massachusetts 02115-6084 |
UCSF School of Medicine | San Francisco, California 94143-0106 |
University of Miami Cancer Center | Miami, Florida 33136 |
C.S. Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota 55404-4597 |
Children's Hospital New York-Presbyterian | New York, New York 10032 |
Miller Children's Hospital | Long Beach, California 90806 |
Children's Memorial | Chicago, Illinois 60614 |
Oakland Children's Hospital | Oakland, California |
University of Minnesota Children's Hospital | Minneapolis, Minnesota |
Nationwide Childrens Hospital | Columbus, Ohio |
Levine Children's Hospital at Carolinas Medical Center | Charlotte, North Carolina 28203 |
Children's Healthcare of Atlanta, Emory University | Atlanta, Georgia |
St. Jude | Memphis, Tennessee 38105-3678 |
The Children's Hospital, University of Colorado | Aurora, Colorado 80045 |