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NCT00254163 · ClinicalTrials.gov registry record · Phase 3
Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients
A Phase 3 study, sponsored by US Oncology Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT00254163: Completed Phase 3 study, sponsored by US Oncology Research.
NCT00254163 is a Phase 3 study that has completed, run by US Oncology Research. The registered enrollment target is 184 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254163, a Phase 3 study, has completed, sponsored by US Oncology Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.
Primary Outcome
infection=febrile events requiring treatment
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Pentostatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2003-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00254163 record still lists
NCT00254163 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00254163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00254163 about?
NCT00254163 is a clinical study titled "Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients". The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these com...
What is the current status of trial NCT00254163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2003-12. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00254163?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Pentostatin (DRUG).
Who is sponsoring clinical trial NCT00254163?
This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00254163's enrollment target sits among peer trials
184 1418th of 2000 higher than 581 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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