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

Completed · Phase 2

Conditions studied: Leukemia

In brief

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).

Key facts

Study ID

NCT00323557

Run by

M.D. Anderson Cancer Center

People needed

39

Starts

2004-06-01

Expected to finish

2011-05-01

Last updated by the study team

2012-12-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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