Trial Information

Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

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 urine 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.

- If you are randomized to the vaccine alone group, you will receive the pneumococcal
vaccine on the first day.

Blood tests will be performed on the day of the pneumococcal vaccination, and 4 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.

If after 6 months of your first vaccination your body is not able to show immunity to
pneumococcal infection, you will receive a second dose either pneumococcal vaccine plus
sargramostim or pneumococcal vaccine alone. Your immunity will be checked again at 4 weeks,
12 weeks, and 24 weeks after this second dose. Only 4 teaspoon of blood will be required for
the tests.

You may be removed from the study if you have a severe allergic reaction to the sargramostim
and/or pneumococcal vaccine. The total maximum time you will be on this is study is 24
months.

This is an investigational study. Both of the medications used in this study are approved
by the FDA. Up to 50 patients may be treated on this study. All will be enrolled at M.D.
Anderson.