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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: Completed Phase 1 study of Cancer and Leukemia, sponsored by Baylor College of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00586547 record still lists
NCT00586547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00586547's enrollment target sits among peer trials
11 599th of 615 higher than 16 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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