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NCT00928200 · ClinicalTrials.gov registry record · Phase 1
Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00928200: Clinical Trial Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT00928200 is a Phase 1 study that was terminated before completion, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928200, a Phase 1 study, was terminated before completion, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.
Primary Outcome
The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Cytarabine
- DRUG Erwinase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-04-13 |
| Est. Completion | 2010-06-04 |
| Phase | Phase 1 |
Why NCT00928200 stopped before completion
NCT00928200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT00928200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00928200 about?
NCT00928200 is a clinical study titled "Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)". This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug int...
What is the current status of trial NCT00928200?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2009-04-13. Estimated completion is 2010-06-04.
What interventions are being tested in trial NCT00928200?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Cytarabine (DRUG), Erwinase (DRUG).
Who is sponsoring clinical trial NCT00928200?
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 NCT00928200's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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