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NCT00326417 · ClinicalTrials.gov registry record · Phase 1
Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT00326417: Completed Phase 1 study, sponsored by Medical College of Wisconsin.
NCT00326417 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326417, a Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of the current study is to continue to optimize conditioning regimens in high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible unrelated donors. Specifically, the study will determine whether the addition of fludarabine to the conditioning regimen previously described by Deeg et al. will permit a reduction in the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths is reduced.
Primary Outcome
DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10\^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant.
Interventions
- DRUG Fludarabine
- DRUG Cyclophosphamide 50mg
- DRUG Cyclophosphamide 150mg
- DRUG Cyclophosphamide 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2006-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT00326417 record still lists
NCT00326417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00326417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00326417 about?
NCT00326417 is a clinical study titled "Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)". The purpose of the current study is to continue to optimize conditioning regimens in high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible unrelated donors. Specifically, the study will determine whether the addition of fludarabine to the conditioning regimen pr...
What is the current status of trial NCT00326417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2006-01. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00326417?
The interventions under investigation include: Fludarabine (DRUG), Cyclophosphamide 50mg (DRUG), Cyclophosphamide 150mg (DRUG), Cyclophosphamide 100mg (DRUG).
Who is sponsoring clinical trial NCT00326417?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00326417's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 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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