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NCT00602459 · ClinicalTrials.gov registry record · Phase 2
Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 418
- Enrollment target
NCT00602459: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00602459 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 418 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (214% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602459, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 418 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
Primary Outcome
Proportion of participants who were alive and progression free at 2 years.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- BIOLOGICAL Rituximab
- DRUG Fludarabine Phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2008-01-15 |
| Est. Completion | 2023-04-15 |
| Phase | Phase 2 |
What the finished NCT00602459 record still lists
NCT00602459 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (214% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00602459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00602459 about?
NCT00602459 is a clinical study titled "Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia". This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, ...
What is the current status of trial NCT00602459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 418 participants. The study started on 2008-01-15. Estimated completion is 2023-04-15.
What interventions are being tested in trial NCT00602459?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Rituximab (BIOLOGICAL), Fludarabine Phosphate (DRUG).
Who is sponsoring clinical trial NCT00602459?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00602459's enrollment target sits among peer trials
418 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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