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NCT00506857 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT00506857: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00506857 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506857, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
Objectives: 1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT). 2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily. 3. In vivo determination of fludarabine inhibitory effects on DNA repair.
Primary Outcome
Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where "toxicity" is defined as grade 3 or 4 conventional toxicity \[National Cancer Institute Common Toxicity Criteria (NCI-CTC)\]. Participant evaluation in a cohort with each modality is 30 days.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2003-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT00506857 record still lists
NCT00506857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT00506857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00506857 about?
NCT00506857 is a clinical study titled "Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support". Objectives: 1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell tr...
What is the current status of trial NCT00506857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2003-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00506857?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00506857?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00506857's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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