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NCT01186328 · ClinicalTrials.gov registry record · Phase 1
EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01186328: Clinical Trial Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01186328 is a Phase 1 study that was terminated before completion, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01186328, a Phase 1 study, was terminated before completion, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is to find out the dose of EZN-3042 that can be safely given without serious side effects both alone and in combination with standard chemotherapy drugs during re-induction.
Primary Outcome
To determine the recommended dose of EZN-3042 administered weekly in combination with re-induction chemotherapy. Based on disease response at Day 36 and toxicity profile assessed until 30 days after discontinuation of study drug.
Interventions
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Prednisone
- DRUG Cytarabine
- DRUG EZN-3042
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-08-24 |
| Est. Completion | 2012-01-10 |
| Phase | Phase 1 |
Why NCT01186328 stopped before completion
NCT01186328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT01186328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01186328 about?
NCT01186328 is a clinical study titled "EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)". An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is to find out the dose of EZN-3042 that can be safely given without serious side effects both alone and in combinatio...
What is the current status of trial NCT01186328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-08-24. Estimated completion is 2012-01-10.
What interventions are being tested in trial NCT01186328?
The interventions under investigation include: Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Cytarabine (DRUG), EZN-3042 (DRUG).
Who is sponsoring clinical trial NCT01186328?
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 NCT01186328's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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