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NCT00630253 · ClinicalTrials.gov registry record · Phase 1
Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00630253: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00630253 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630253, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem cell transplant helps to remove the patient's cells to allow for the transplant cells to take and grow. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant and giving cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide, fludarabine, and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with Fanconi anemia.
Primary Outcome
graft failure = absolute neutrophil count (ANC) \<5 x 10\^8/L and an acellular bone marrow aspirate/biopsy
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-Thymocyte Globulin
- DRUG Methylprednisolone
- PROCEDURE Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2000-02-17 |
| Est. Completion | 2020-10-10 |
| Phase | Phase 1 |
What the finished NCT00630253 record still lists
NCT00630253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00630253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00630253 about?
NCT00630253 is a clinical study titled "Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia". RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem cell transplant helps to remove the patient's cells to allow for the transplant cells to take and grow. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy...
What is the current status of trial NCT00630253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2000-02-17. Estimated completion is 2020-10-10.
What interventions are being tested in trial NCT00630253?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Methylprednisolone (DRUG), Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00630253?
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 NCT00630253's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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