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NCT00513747 · ClinicalTrials.gov registry record · Phase 3
Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT00513747: Clinical Trial Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00513747 is a Phase 3 study that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513747, a Phase 3 study, was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia.
Primary Outcome
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.
Interventions
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2008-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
Why NCT00513747 stopped before completion
NCT00513747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which rituximab is the first listed.
NCT00513747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513747 about?
NCT00513747 is a clinical study titled "Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia". RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer ...
What is the current status of trial NCT00513747?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2008-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00513747?
The interventions under investigation include: rituximab (BIOLOGICAL), fludarabine phosphate (DRUG).
Who is sponsoring clinical trial NCT00513747?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00513747's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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