CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
AC220 +3 moredrug
Likely dose
Cytarabine 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01411267
NCT01411267Phase 1Completed
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A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML

Therapeutic Advances in Childhood Leukemia Consortium·interventional·Posted Aug 8, 2011·Updated Apr 4, 2022

In Brief

A Phase 1 clinical trial evaluating AC220, Cytarabine, and 2 other interventions for Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood. Completed, enrolled 24 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoblastic Leukemia, Acute, Childhood, Myelogenous Leukemia, Acute, Childhood
CountriesUnited States
CollaboratorsAmbit Biosciences Corporation

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 12, 2013
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 14.9 years ago

Interventions

AC220drug

Dose assigned at study entry. AC220 will be given orally once daily on days 7-28.

Cytarabinedrug

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

Etoposidedrug

150 mg/m2/day IV on days 1 through 5.

Methotrexatedrug

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