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NCT00586547 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation
A Phase 1 study of Cancer and Leukemia, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT00586547 is a Phase 1 study of Cancer and Leukemia that has completed, run by Baylor College of Medicine. The registered enrollment target is 11 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00586547, a Phase 1 study of Cancer and Leukemia, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of \< / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.
Interventions
- BIOLOGICAL T-Cell Infusion Dose Level -1
- BIOLOGICAL T-Cell Infusion Dose Level 1
- BIOLOGICAL T-Cell Infusion Dose Level 2
- BIOLOGICAL T-Cell Infusion Dose Level 3
- BIOLOGICAL T-Cell Infusion- Dose Level 4
Study Locations (2)
Texas
- Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2000-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586547
The ClinicalTrials.gov registry entry for NCT00586547 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 5 interventions - of which T-Cell Infusion Dose Level -1 is the first listed.
NCT00586547 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00586547 about?
NCT00586547 is a clinical study titled "Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation". This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GV...
What is the current status of trial NCT00586547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2000-07. Estimated completion is 2008-09.
What conditions does trial NCT00586547 study?
This clinical trial studies the following conditions: Cancer, Leukemia.
What interventions are being tested in trial NCT00586547?
The interventions under investigation include: T-Cell Infusion Dose Level -1 (BIOLOGICAL), T-Cell Infusion Dose Level 1 (BIOLOGICAL), T-Cell Infusion Dose Level 2 (BIOLOGICAL), T-Cell Infusion Dose Level 3 (BIOLOGICAL), T-Cell Infusion- Dose Level 4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00586547?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00586547 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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