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NCT00638820 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity AlloTransplant For Osteopetrosis
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00638820: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00638820 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00638820, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. However, we have found in past studies that approximately 30% of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a different combination of pre-transplant drugs to try to make transplants safer for this disease, as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors. The purpose of this research is to find a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis, using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality.
Primary Outcome
Number of patients with persistent presence of donor-derived cells at Day 100
Interventions
- PROCEDURE Stem Cell or Umbilical Cord Blood Transplantation
- DRUG Campath, Busulfan, Clofarabine
- PROCEDURE Total Lymphoid Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
Why NCT00638820 stopped before completion
NCT00638820 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Stem Cell or Umbilical Cord Blood Transplantation is the first listed.
NCT00638820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00638820 about?
NCT00638820 is a clinical study titled "Reduced Intensity AlloTransplant For Osteopetrosis". We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. Howev...
What is the current status of trial NCT00638820?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2007-09. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00638820?
The interventions under investigation include: Stem Cell or Umbilical Cord Blood Transplantation (PROCEDURE), Campath, Busulfan, Clofarabine (DRUG), Total Lymphoid Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT00638820?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00638820's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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