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NCT01411267 · ClinicalTrials.gov registry record · Phase 1
AC220 for Children With Relapsed/Refractory ALL or AML
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01411267: Completed Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01411267 is a Phase 1 study that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01411267, a Phase 1 study, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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).
Primary Outcome
The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. Plasma inhibitor activity (PIA) will be measured Pre-treatment and on Days 7, 14, 21 and 28 of Course 1. For the MTD to be considered biologically active, we will require that 7 of 9 patients achieve PIA of \> 90% at 3 of 4 trough time points.
Interventions
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Methotrexate
- DRUG AC220
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09-01 |
| Est. Completion | 2013-09-12 |
| Phase | Phase 1 |
What the finished NCT01411267 record still lists
NCT01411267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Etoposide is the first listed.
NCT01411267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01411267 about?
NCT01411267 is a clinical study titled "AC220 for Children With Relapsed/Refractory ALL or AML". 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).
What is the current status of trial NCT01411267?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09-01. Estimated completion is 2013-09-12.
What interventions are being tested in trial NCT01411267?
The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Methotrexate (DRUG), AC220 (DRUG).
Who is sponsoring clinical trial NCT01411267?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01411267's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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