Trial Outcomes & Findings for Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients (NCT NCT00323557)

Results Overview

Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Baseline and at 1 month after vaccine.

Results posted on

2012-12-05

Participant Flow

Recruitment Period: December 9, 2004 to July 16, 2009. All participants were recruited at UT MD Anderson Cancer Center.

Of the 39 enrolled participants, four (4) participants withdrew consent and three (3) were ineligible thus all seven (7) were excluded from the trial before assignment to Pneumococcal Vaccine and Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) related treatment groups.

Participant milestones

Participant milestones
Measure	Pneumococcal Vaccine + GM-CSF Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.	Pneumococcal Vaccine Alone First vaccine dose subcutaneously, Day 0.
Overall Study STARTED	25	7
Overall Study COMPLETED	24	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pneumococcal Vaccine + GM-CSF Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.	Pneumococcal Vaccine Alone First vaccine dose subcutaneously, Day 0.
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pneumococcal Vaccine + GM-CSF n=25 Participants Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.	Pneumococcal Vaccine Alone n=7 Participants First vaccine dose subcutaneously, Day 0.	Total n=32 Participants Total of all reporting groups
Age Continuous	70 years n=93 Participants	61 years n=4 Participants	68 years FULL_RANGE 10 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	3 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	4 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment United States	25 participants n=93 Participants	7 participants n=4 Participants	32 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and at 1 month after vaccine.

Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.

Outcome measures

Outcome measures
Measure	Pneumococcal Vaccine + Post Vaccine GM-CSF n=12 Participants Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.	Pneumococcal Vaccine Alone n=7 Participants First vaccine dose subcutaneously, Day 0. No CM-CSF.	Pneumococcal Vaccine + Pre Vaccine GM-CSF n=13 Participants Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 4	0 participants	1 participants	0 participants 5
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 6B	1 participants	0 participants	1 participants
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 9V	1 participants	1 participants	1 participants
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 14	2 participants	0 participants	2 participants 66
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 19F	0 participants	1 participants	2 participants
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine Pneumococcal Serotype 23F	1 participants	1 participants	2 participants

Adverse Events

Pneumococcal Vaccine + GM-CSF

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Pneumococcal Vaccine Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pneumococcal Vaccine + GM-CSF n=25 participants at risk Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.	Pneumococcal Vaccine Alone n=7 participants at risk First vaccine dose subcutaneously, Day 0.
Skin and subcutaneous tissue disorders Pain and redness at injection site	24.0% 6/25 • 6 years and 6 months	14.3% 1/7 • 6 years and 6 months
Skin and subcutaneous tissue disorders Palmar Erythema	4.0% 1/25 • 6 years and 6 months	0.00% 0/7 • 6 years and 6 months
Investigations Low grade fever	8.0% 2/25 • 6 years and 6 months	0.00% 0/7 • 6 years and 6 months

Additional Information

Amar Safdar, MD/Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place