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NCT00409695 · ClinicalTrials.gov registry record · Phase 1
Thymoglobulin (ATG) Dose Finding Study
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00409695: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00409695 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00409695, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the response and toxicity rate at day 56 of two different dose levels of thymoglobulin (ATG) \[anti-thymocyte globulin (rabbit)\] as a treatment of steroid-refractory acute graft versus host disease (aGVHD). Secondary Objectives: * To evaluate the response rate at day 28. * To evaluate the overall survival and non-relapse mortality at 6 months. * To determine the toxicity profile of thymoglobulin when used for the treatment of steroid-refractory aGVHD in each of two dose schedules. * To characterize the pharmacokinetic profile of thymoglobulin in each of two dose schedules. * To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims of finding the minimal effective dose. * To determine immune-reconstitution after administration of thymoglobulin to patients with steroid-refractory aGVHD for each dose schedule.
Interventions
- DRUG Low Dose Thymoglobulin (ATG)
- DRUG High Dose Thymoglobulin (ATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00409695
The ClinicalTrials.gov registry entry for NCT00409695 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 M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Dose Thymoglobulin (ATG) is the first listed.
NCT00409695 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00409695 about?
NCT00409695 is a clinical study titled "Thymoglobulin (ATG) Dose Finding Study". Primary Objective: * To determine the response and toxicity rate at day 56 of two different dose levels of thymoglobulin (ATG) \[anti-thymocyte globulin (rabbit)\] as a treatment of steroid-refractory acute graft versus host disease (aGVHD). Secondary Objectives: * To evaluate the response rate a...
What is the current status of trial NCT00409695?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2006-12. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00409695?
The interventions under investigation include: Low Dose Thymoglobulin (ATG) (DRUG), High Dose Thymoglobulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT00409695?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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