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NCT00578539 · ClinicalTrials.gov registry record · NA
T-Reg Cell Kinetics, Stem Cell Transplant, REGALE
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT00578539: Clinical Trial NA study, sponsored by Baylor College of Medicine.
NCT00578539 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578539, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting a treatment that might help patients live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help patients as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant. Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to recipient. Patients do not have a sibling that is a perfect match, so the stem cells will come from a donor who is the best match available. This person may be a close relative or an unrelated person whose stem cells best "matches" the patients, and who agrees to donate stem cells. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets. This research study will also use CAMPATH-1H as a pre-treatment. CAMPATH-1H is an antibody against certain types of blood cells. CAMPATH-1H is important because it stays active in the body for a long time a
Primary Outcome
To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol
Interventions
- DRUG Cyclophosphamide
- RADIATION Total Body Irradiation (TBI)
- DRUG MESNA
- DRUG ARA C
- BIOLOGICAL Campath-1h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-05 |
| Phase | NA |
Why NCT00578539 stopped before completion
NCT00578539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00578539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00578539 about?
NCT00578539 is a clinical study titled "T-Reg Cell Kinetics, Stem Cell Transplant, REGALE". Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting a treatment that might help patients live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help patients as it allows us to give...
What is the current status of trial NCT00578539?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2007-10. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00578539?
The interventions under investigation include: Cyclophosphamide (DRUG), Total Body Irradiation (TBI) (RADIATION), MESNA (DRUG), ARA C (DRUG), Campath-1h (BIOLOGICAL).
Who is sponsoring clinical trial NCT00578539?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00578539's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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