A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
1 to 21, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01411267
Protocol IDs
T2009-004 (primary)
Study Sponsor
Therapeutic Advances in Childhood Leukemia Consortium

Summary

This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).

Objectives

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.

Treatment Sites in Georgia


Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD
Muna Qayed MD

Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite
5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD