Status:
COMPLETED
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer
Conditions:
Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 w...
Detailed Description
Sargramostim (also commonly called granulocyte macrophage colony stimulating factor - GM-CSF) is a medication used to stimulate the bone marrow production of white blood cells before a stem cell trans...
Eligibility Criteria
Inclusion
- 1\) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00323557
Start Date
June 1 2004
End Date
May 1 2011
Last Update
December 5 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030