Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Sargramostim (Drug); Pneumococcal Vaccine (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Amar Safdar, MD, Principal Investigator, Affiliation: U.T.M.D. Anderson Cancer Center
Summary
Primary Objective:
1. To evaluate efficacy of GM-CSF-mediated enhanced seroconversion (protective
anti-pneumococcal serum immunoglobulins) in patients receiving conventional 23-valent
capsular polysaccharide pneumococcal vaccine (PPV) and 7-valent Pneumococcal conjugated
vaccine (PCV7) while undergoing treatment for advanced chronic lymphocytic leukemia (CLL).
Secondary Objective:
1. To evaluate the effect of GM-CSF on the dendritic cells and cytokine production in CLL
patients.
Clinical Details
Official title: Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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).
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 transplant, after chemotherapy or after a bone marrow transplant. Pneumococcal
vaccine is a medication used to prevent infections caused by a bacteria called Streptococcus
pneumoniae.
If you have not had a gammaglobulins test (a test to measure immunity against certain
infectious diseases) measured within three months before the study begins, then this blood
test will be done before you receive any study medications.
Women who are able to have children must have a negative blood pregnancy test before starting
treatment.
After consenting to this study, you will be randomly assigned (as in the toss of a coin) to
receive treatment with sargramostim in addition to the pneumococcal vaccine or to receive
pneumococcal vaccine alone (Prevnar).
If you are randomized to vaccine plus sargramostim group, you will receive an injection of
sargramostim at the same time you receive the pneumococcal vaccine. A second dose of
pneumococcal vaccine with sargramostim will be given 6 weeks after the first vaccination.
If you are randomized to the vaccine alone group, you will receive the pneumococcal vaccine
on the first day and 6 weeks after the first vaccine dose. You will have your blood tested as
described below.
Blood tests will be performed on the day of the pneumococcal vaccination, and 6 weeks, 12
weeks and 24 weeks after vaccination. Each of the blood tests will require about 4
teaspoons of blood. These blood tests will measure your immunity to pneumococcal infection.
You may be removed from the study if you have a severe allergic reaction to the sargramostim.
The total time you will be on this is study is 24 weeks.
This is an investigational study. Both of the medications used in this study are approved by
the FDA. Up to 64 patients may be treated on this study. All will be enrolled at M. D.
Anderson.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with Rai stage (0 to 4) CLL.
- No prior Campath or fludarabine-based therapy within 12 months.
- No prior Rituximab® within 6 months.
Exclusion Criteria:
- Patients will not be entered while neutropenic (PMNs < 500 cells/mm3).
- Patients will not be entered while febrile (T > 38 degrees C) within 1 week.
- Active infection.
- Patients with known HIV infection.
- Known history of allergy to GM-CSFor 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
Locations and Contacts
U.T. M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Starting date: June 2004
Last updated: June 6, 2008
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