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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00323557
First received: May 5, 2006
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: April 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Sargramostim (GM-CSF)
Biological: Pneumococcal Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: December 9, 2004 to July 16, 2009. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Pneumococcal Vaccine + GM-CSF     Pneumococcal Vaccine Alone  
STARTED     25 [1]   7  
COMPLETED     24     7  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  
[1] GM-CSF pre and post vaccine.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Pneumococcal Vaccine + GM-CSF     Pneumococcal Vaccine Alone     Total  
Number of Participants  
[units: participants]
  25     7     32  
Age  
[units: years]
Median ( Full Range )
  70  
  ( 51 to 91 )  
  61  
  ( 57 to 77 )  
  68  
  ( 51 to 91 )  
Gender  
[units: participants]
     
Female     12     3     15  
Male     13     4     17  
Region of Enrollment  
[units: participants]
     
United States     25     7     32  



  Outcome Measures

1.  Primary:   Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine   [ Time Frame: Baseline and at 1 month after vaccine. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Amar Safdar, MD/Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00323557     History of Changes
Other Study ID Numbers: 2003-0605
Study First Received: May 5, 2006
Results First Received: April 6, 2012
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board