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NCT00586274 · ClinicalTrials.gov registry record · Phase 1
Use of Rft5-Dga to Deplete Alloreactive Cells for Pts With Fanconi Anemia After Haploidentical SCT
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00586274 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT00586274, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
While stem cell transplantation has proven an effective means of treating a wide variety of diseases involving hematopoietic stem cells and their progeny, a shortage of donors has proved a major impediment to the widest application of the approach. Until recently, only MHC identical donors could be used with safety. Such donors were originally siblings or other closely related family members. Over the past decade, the growth of allogeneic donor panels has allowed transplantation with stem cells obtained from a volunteer donor panel. While it is now possible to obtain HLA identical unrelated donor stem cells for approximately 75% of individuals of Northern European backgrounds, the situation for most other ethnic groups is much less satisfactory. Even when a matched donor can be found, the elapsed time between commencing the search and collecting the stem cells usually exceeds three months, a delay that may doom many of the neediest patients. Hence there has been considerable interest in making use of HLA haploidentical family donors. Most individuals have a first-degree relative who would be suitable for such protocols. Fanconi anemia (FA) is an autosomal recessive disorder characterized by the development of progressive aplastic anemia usually evident by about age seven years and often associated with various diverse congenital anomalies such as short stature, microcephaly, radial anomalies, horseshoe kidney, and cafe au lait spots. This study will determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants with Fanconi anemia 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%.
Interventions
- DRUG Fludarabine
- PROCEDURE CD34 selected haploidentical PBSCT
- BIOLOGICAL T cell infusion
- BIOLOGICAL Campath 1h
- BIOLOGICAL anti-CD45
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2002-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586274
The ClinicalTrials.gov registry entry for NCT00586274 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 Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00586274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00586274 about?
NCT00586274 is a clinical study titled "Use of Rft5-Dga to Deplete Alloreactive Cells for Pts With Fanconi Anemia After Haploidentical SCT". While stem cell transplantation has proven an effective means of treating a wide variety of diseases involving hematopoietic stem cells and their progeny, a shortage of donors has proved a major impediment to the widest application of the approach. Until recently, only MHC identical donors could be ...
What is the current status of trial NCT00586274?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2002-03. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00586274?
The interventions under investigation include: Fludarabine (DRUG), CD34 selected haploidentical PBSCT (PROCEDURE), T cell infusion (BIOLOGICAL), Campath 1h (BIOLOGICAL), anti-CD45 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00586274?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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