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NCT00056979 · ClinicalTrials.gov registry record · Phase 1
Monoclonal Antibody Conditioning for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00056979 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 2 participants.
The verdict
NCT00056979, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study treats patients with an inherited disease that prevents the body from making a specific protein or enzyme needed for the body's metabolism. Lack of this enzyme causes accumulation of harmful or toxic substances in the body, which leads to deterioration and failure of organs such as the brain or the heart. This disease can be fatal. Some patients with inherited metabolic storage disease may benefit from an allogeneic stem cell transplant ('allogeneic' means that the stem cells come from another person). Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. Stem cells, when transplanted, can make a new blood system. Donor stem cells can make the protein or enzyme patients with this disease cells cannot. The donor cells may prevent further accumulation of toxic substances. It is hoped that the donor cells can prevent or stop the disease from progressing. This research study uses a new pre-treatment combination of two drugs, Anti-CD45 and CAMPATH-1H. Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells. CAMPATH-1H is particularly important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GVHD symptoms. In addition to antibodies, patients will receive Fludarabine, which is a chemotherapy drug. Fludarabine kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells may 'take.'
Interventions
- DRUG Fludarabine
- DRUG CAMPATH-1H
- DRUG Anti-CD45
- DRUG FK506
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2002-06 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00056979
The ClinicalTrials.gov registry entry for NCT00056979 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 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 4 interventions - of which Fludarabine is the first listed.
NCT00056979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00056979 about?
NCT00056979 is a clinical study titled "Monoclonal Antibody Conditioning for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases". This study treats patients with an inherited disease that prevents the body from making a specific protein or enzyme needed for the body's metabolism. Lack of this enzyme causes accumulation of harmful or toxic substances in the body, which leads to deterioration and failure of organs such as the br...
What is the current status of trial NCT00056979?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2002-06. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00056979?
The interventions under investigation include: Fludarabine (DRUG), CAMPATH-1H (DRUG), Anti-CD45 (DRUG), FK506 (DRUG).
Who is sponsoring clinical trial NCT00056979?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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