Phase 2
N=32
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00323557 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine — 0; 0; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sargramostim (GM-CSF) (Drug); Pneumococcal Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine |
0; 0; 1; 1; 1; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.
Exclusion Criteria
- Patients will not be entered while neutropenic (PMNs 38 degrees C) within 1 week.
- Active infection.
- Patients with known Human immunodeficiency virus (HIV) infection.
- Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine.
- Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.
- Patients who have previously received pneumococcal vaccine within the preceding 12 months.
- Absolute lymphocyte count less than 500 cells/mm3.
Data sourced from ClinicalTrials.gov (NCT00323557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.