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

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Leukemia
Interventions
DRUG

Sargramostim (GM-CSF)

Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.

BIOLOGICAL

Pneumococcal Vaccine

Subcutaneously on Day 0

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER