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NCT00579137 · ClinicalTrials.gov registry record · Phase 1
Allogeneic SCT Of Pts With SCID And Other Primary Immunodeficiency Disorders
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00579137: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT00579137 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579137, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study is to discover whether children with severe combined immunodeficiency disease (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment other than stem cell transplantation (SCT) exists can be safely and effectively transplanted from HLA mismatched (up to one haplotype) related donors or unrelated matched or mismatched (up to one antigen) donors, when leukocytolytic monoclonal antibodies (MAb) and Fludarabine are the sole conditioning agents. Three monoclonal antibodies will be used in combination. Two of them are rat IgG1 (immunoglobulin G1) antibodies directed against two contiguous epitopes on the CD45 (common leucocyte) antigen. They have been safely administered as part of the conditioning regimen for 12 patients receiving allografts (HLA matched and mismatched) at this center. They produce a transient depletion of \>90% circulating leucocytes. The third MAb is Campath 1H, a humanized rat anti-CD52 MAb. Campath 1H, Alemtuzumab, has been licensed to treat B-cell chronic lymphocytic leukemia (B-CLL) and more recently has been safely given at this and other centers as part of a sub-ablative conditioning regimen to patients with malignant disease. Because these MAb produce both profound immunosuppression and significant, though transient, myelodestruction we believe they may be useful as the sole conditioning regimen in patients with SCID, in whom the use of conventional chemotherapeutic agents for conditioning may produce or aggravate unacceptable and even lethal short term toxicity. We anticipate MAb mediated subablative conditioning will permit engraftment in a high percentage of these patients with little or no immediate or long term toxicity. Campath IH persists in vivo for several days after administration and so will be present over the transplant period to deplete donor T cells as partial GvHD prophylaxis. Additional Graft versus Host Disease (GvHD) prophylaxis may be provided by administration of FK506.
Interventions
- DRUG Fludarabine
- PROCEDURE Stem cell infusion
- BIOLOGICAL Anti-CD45
- BIOLOGICAL Campath -1H
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
Why NCT00579137 stopped before completion
NCT00579137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00579137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00579137 about?
NCT00579137 is a clinical study titled "Allogeneic SCT Of Pts With SCID And Other Primary Immunodeficiency Disorders". This study is to discover whether children with severe combined immunodeficiency disease (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment other than stem cell transplantation (SCT) exists can be safely and effectively transplanted from HLA mismatched (up to...
What is the current status of trial NCT00579137?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-10. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00579137?
The interventions under investigation include: Fludarabine (DRUG), Stem cell infusion (PROCEDURE), Anti-CD45 (BIOLOGICAL), Campath -1H (BIOLOGICAL).
Who is sponsoring clinical trial NCT00579137?
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 NCT00579137's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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