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NCT00578292 · ClinicalTrials.gov registry record · NA
Allogeneic Stem Cell Transplantation, Severe Homzygous 0/+Thalassemia or Sever Variants of Beta 0/+ Thalassemia, THALLO
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT00578292 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT00578292, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Patients have severe beta-thalassemia or one of the thalassemia variants. Thalassemia is a hereditary disease in which the bone marrow produces abnormal red blood cells that have a shorter life span than normal red blood cells. Because of that, the patient has chronically low red blood cell numbers (anemia) and need regular blood transfusions to help the patient feel better and to help prevent damage to important organs such as the heart. The following treatments are currently available to patients: lifelong blood transfusions and drugs that help remove iron from the body, and long-term antibiotics to prevent infections. These treatments are difficult for patients to take, and do not stop the effects of the disease. Currently, the only treatment that may cure thalassemia is bone marrow or blood stem cell transplantation. Special blood or bone marrow cells from a healthy person might allow the bone marrow to create healthy cells, which will replace the abnormal red blood cells of thalassemia. There is a lot of experience using special blood or bone marrow cells from a healthy brother or sister who is the same HLA (immune) type. For patients who do not have such a donor in the family, an unrelated volunteer donor can be used. It is important for the patient to realize that this kind of transplant can have more problems than a transplant from a brother or sister. Because we do not know the long-term effects of this treatment and because this type of transplant has not been used often for people with thalassemia, this is a research study. We hope, but cannot promise, that the transplanted marrow/stem cells will produce healthy cells and the patient will no longer have severe thalassemia.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG MESNA
- DRUG Campath 1H
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-02 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578292
The ClinicalTrials.gov registry entry for NCT00578292 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 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 Cyclophosphamide is the first listed.
NCT00578292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578292 about?
NCT00578292 is a clinical study titled "Allogeneic Stem Cell Transplantation, Severe Homzygous 0/+Thalassemia or Sever Variants of Beta 0/+ Thalassemia, THALLO". Patients have severe beta-thalassemia or one of the thalassemia variants. Thalassemia is a hereditary disease in which the bone marrow produces abnormal red blood cells that have a shorter life span than normal red blood cells. Because of that, the patient has chronically low red blood cell numbers ...
What is the current status of trial NCT00578292?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2004-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT00578292?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), MESNA (DRUG), Campath 1H (DRUG).
Who is sponsoring clinical trial NCT00578292?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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