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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00928200
The ClinicalTrials.gov registry entry for NCT00928200 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT00928200 reports 0 study locations.
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.
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