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NCT00328198 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT00328198: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT00328198 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00328198, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.
Primary Outcome
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with incre
Interventions
- BIOLOGICAL Alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00328198 record still lists
NCT00328198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Alemtuzumab is the first listed.
NCT00328198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00328198 about?
NCT00328198 is a clinical study titled "Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia". This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.
What is the current status of trial NCT00328198?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2006-05. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00328198?
The interventions under investigation include: Alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00328198?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00328198's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 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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