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NCT00092937 · ClinicalTrials.gov registry record · Phase 1
Use of Busulfan as Conditioning Agent for a Second Stem Cell Transplant
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00092937: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00092937 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00092937, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This protocol is designed for a single specific patient. It uses busulfan as a conditioning agent in a second stem cell transplant procedure for a patient with chronic granulomatous disease (CGD), a disorder in which a certain type of white cells, called myeloid cells, do not function properly. This causes increased risk of serious bacterial and fungal infections that can lead to organ dysfunction, such as kidney disease, as well as formation of granulomas-non-cancerous masses that can cause obstructions in the esophagus, stomach, and intestines, and block urine flow from the kidneys and bladder.). The child in this study has previously undergone a stem cell transplant to treat CGD, and, as a result, he is now producing normal lymphocytes (another type of white cell). However, the myeloid cells from the donor did not engraft successfully, and the patient is still producing his own defective myeloid cells. In this study, the child will undergo a second stem cell transplant in combination with busulfan, a drug that targets myeloid cells, killing them to make way for healthy, donated myeloid cells. Treatment includes the following procedures: * Medical evaluation to confirm that the patient is healthy enough to undergo the transplantation * Treatment with busulfan, injected through the patient's central venous line * Stem cell transplantation through the central venous line * Blood tests on days 25, 56, and 91 after the transplant to assess how many cells are of donor origin * Bone marrow aspiration on day 100, and then at 12, 24, and 36 months to assess how many cells are of donor origin * Pulmonary function (breathing) test at 12 and 24 months * Physical examination and blood tests, weekly or twice weekly for the first 2 to 3 months and at 4, 6, 12, 18, 24, 36, 48, and 60 months after transplant * Treatment for graft-versus-host disease (GVHD), if this complication develops. GVHD is the attack of lymphocytes from the donor against the patient's own cells. This is g
Interventions
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2004-09-23 |
| Est. Completion | 2010-04-06 |
| Phase | Phase 1 |
What the finished NCT00092937 record still lists
NCT00092937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Busulfan is the first listed.
NCT00092937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00092937 about?
NCT00092937 is a clinical study titled "Use of Busulfan as Conditioning Agent for a Second Stem Cell Transplant". This protocol is designed for a single specific patient. It uses busulfan as a conditioning agent in a second stem cell transplant procedure for a patient with chronic granulomatous disease (CGD), a disorder in which a certain type of white cells, called myeloid cells, do not function properly. This...
What is the current status of trial NCT00092937?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2004-09-23. Estimated completion is 2010-04-06.
What interventions are being tested in trial NCT00092937?
The interventions under investigation include: Busulfan (DRUG).
Who is sponsoring clinical trial NCT00092937?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00092937's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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