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NCT00058825 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant for Hematologic Diseases
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00058825: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT00058825 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058825, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Patients are being asked to participate in this study because they have a cancer in their blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit from an allogeneic stem cell transplant using a donor that is related to the patient. Stem cells are created in the bone marrow. They grow into different types of blood cells that the patient needs, including red blood cells, white blood cells, and platelets. In a transplant, the patient's own stem cells are killed and then replaced by stem cells from the donor. Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant. However, because of the patient's condition, they have a high risk of experiencing life-threatening treatment-related side-effects. Recently, some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant. This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease. We also want to see whether there are fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still being studied. CAMPATH 1H stays active in the body for a long time after patients receive it, which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.
Primary Outcome
Percentage of patients with transplant related mortality
Interventions
- DRUG Fludarabine
- RADIATION Total Body Irradiation (TBI)
- PROCEDURE Stem Cell Transplant
- BIOLOGICAL Campath 1H
- DRUG FK506 (Tacrolimus) or Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2000-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
Why NCT00058825 stopped before completion
NCT00058825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00058825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00058825 about?
NCT00058825 is a clinical study titled "Stem Cell Transplant for Hematologic Diseases". Patients are being asked to participate in this study because they have a cancer in their blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit from an allogeneic stem...
What is the current status of trial NCT00058825?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2000-08. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00058825?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (TBI) (RADIATION), Stem Cell Transplant (PROCEDURE), Campath 1H (BIOLOGICAL), FK506 (Tacrolimus) or Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00058825?
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 NCT00058825's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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