AC220 for Children With Relapsed/Refractory ALL or AML

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 1, 2011

Primary Completion Date

September 12, 2013

Study Completion Date

September 12, 2013

Conditions
Lymphoblastic Leukemia, Acute, ChildhoodMyelogenous Leukemia, Acute, Childhood
Interventions
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"

Trial Locations (11)

21231

Johns Hopkins University, Baltimore

28203

Levine Children's Hospital at Carolinas Medical Center, Charlotte

30322

Children's Healthcare of Atlanta, Emory University, Atlanta

64108

Children's Mercy Hospitals and Clinics, Kansas City

80045

The Children's Hospital, University of Colorado, Aurora

90027

Childrens Hospital Los Angeles, Los Angeles

93636

Children's Hospital Central California, Madera

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

94143-0106

UCSF School of Medicine, San Francisco

02215

Dana Farber, Boston

Sponsors
All Listed Sponsors
collaborator

Ambit Biosciences Corporation

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER

NCT01411267 - AC220 for Children With Relapsed/Refractory ALL or AML | Biotech Hunter | Biotech Hunter