Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bayer
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Molgramostim; Sargramostim; Vaccines

Criteria

Inclusion Criteria:

1) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.

Exclusion Criteria:

1. Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having received Rituximab within 6 months.

2. Patients will not be entered while febrile (Temperature > 38 degrees C) within 1 week.

3. Active infection.

4. Patients with known Human immunodeficiency virus (HIV) infection.

5. Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine.

6. Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.

7. Patients who have previously received pneumococcal vaccine within the preceding 12 months.

8. Absolute lymphocyte count less than 500 cells/mm3.