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NCT00858117 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00858117: Completed Phase 2 study, sponsored by Northwestern University.
NCT00858117 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00858117, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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 alemtuzumab together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.
Primary Outcome
Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets \>100,000/μl, Hemoglobin \> 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes. PR=absence of constitutional sympt
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL Alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-09-26 |
| Est. Completion | 2013-01-24 |
| Phase | Phase 2 |
What the finished NCT00858117 record still lists
NCT00858117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00858117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00858117 about?
NCT00858117 is a clinical study titled "A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL". RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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 alemtuzumab together with rituxima...
What is the current status of trial NCT00858117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-09-26. Estimated completion is 2013-01-24.
What interventions are being tested in trial NCT00858117?
The interventions under investigation include: Rituximab (BIOLOGICAL), Alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00858117?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00858117's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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