NCT01411267

AC220 for Children With Relapsed/Refractory ALL or AML

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Therapeutic Advances in Childhood Leukemia Consortium · Academic / Other
• Sex: All
• Age: 1 Month – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoblastic Leukemia, Acute, Childhood
• Myelogenous Leukemia, Acute, Childhood

Interventions

Type	Name	Description
DRUG	AC220	Dose assigned at study entry. AC220 will be given orally once daily on days 7-28.
DRUG	Cytarabine	All patients receive 1000 mg/m2/day IV given every 12 hours on days 1 through 5. Additionally, AML patients and patients with ambiguous leukemia receive cytarabine intrathecally on day "1" of course 1 and 2. Dose defined by age: * 20 mg for patients age \<1 yr * 30 mg for patients age 1-1.99 years of age * 50 mg for patients age 2-2.99 years of age * 70 mg for patients \>3 years of age
DRUG	Etoposide	150 mg/m2/day IV on days 1 through 5.
DRUG	Methotrexate	IT methotrexate given intrathecally to patients with ALL on day "0" of course 1 and 2. Dose defined by age * 6 mg for patients age \< 1yr * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-12
• Completion: 2013-09-12
• First posted: 2011-08-08
• Last updated: 2022-04-04
• Results posted: 2020-02-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study