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NCT00323557 · ClinicalTrials.gov registry record · Phase 2
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00323557: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00323557 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323557, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
Primary Outcome
Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.
Interventions
- BIOLOGICAL Pneumococcal Vaccine
- DRUG Sargramostim (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2004-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00323557 record still lists
NCT00323557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Pneumococcal Vaccine is the first listed.
NCT00323557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00323557 about?
NCT00323557 is a clinical study titled "Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients". The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
What is the current status of trial NCT00323557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2004-06. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00323557?
The interventions under investigation include: Pneumococcal Vaccine (BIOLOGICAL), Sargramostim (GM-CSF) (DRUG).
Who is sponsoring clinical trial NCT00323557?
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 NCT00323557's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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