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NCT00472849 · ClinicalTrials.gov registry record · Phase 1
Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
NCT00472849: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00472849 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00472849, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation. Once the highest tolerable dose for this drug combination is found, the next goal of the study will be to find out if this combination therapy is effective in shrinking or slowing the growth of these diseases.
Primary Outcome
Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants
Interventions
- DRUG Fludarabine
- DRUG Oxaliplatin
- DRUG Rituximab
- DRUG Cytarabine
- DRUG Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00472849 record still lists
NCT00472849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00472849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00472849 about?
NCT00472849 is a clinical study titled "Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias". The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation. Once the highest ...
What is the current status of trial NCT00472849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2007-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00472849?
The interventions under investigation include: Fludarabine (DRUG), Oxaliplatin (DRUG), Rituximab (DRUG), Cytarabine (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT00472849?
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 NCT00472849's enrollment target sits among peer trials
92 625th of 2000 higher than 1,375 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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