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AC220 for Children With Relapsed/Refractory ALL or AML

NCT01411267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-04

Study results available
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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).

Conditions

  • Lymphoblastic Leukemia, Acute, Childhood
  • Myelogenous 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

Sponsors & Collaborators

  • Ambit Biosciences Corporation

    collaborator INDUSTRY

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Principal Investigators

  • Todd Cooper, MD · Children's Healthcare of Atlanta, Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-01
Primary Completion
2013-09-12
Completion
2013-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01411267 on ClinicalTrials.gov