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Study Summary
No. 2003-0605:.......Leukemia......Amar Safdar......Infectious Disease
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Study Summary Title
Study Summary
Number:		2003-0605
Study Title:Immuno-augmentation with GM-CSF in patients receiving pneumococcal vaccine while undergoing treatment for advanced chronic lymphocytic leukemia (CLL)
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Physician New Patient Referral
Name:Amar SafdarPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Infectious DiseaseReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-0045
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		From one visit up to 4 visits.
Treatment
Agents:		GM-CSF
Pneumococcal Vaccine		Home Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		The goal of this clinical research study is 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).
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Study Objectives / Outcomes
Primary Objective
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) in patients with chronic lymphocytic leukemia (CLL).

Secondary Objective
To evaluate the effect of GM-CSF on the dendritic cells and cytokine production in CLL patients.
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Study Status Information
Study Activation / Registration Date:06/18/2004
IRB Review and Approval Date:11/05/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual: a maximum 101
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients in complete / partial remission or those with active CLL with Rai stage 0 to 4.
Exclusion Criteria:1) Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having received Rituximab within 6 months.

2) Patients will not be entered while febrile (T > 38 degrees C) within 1 week.

3) Active infection.

4) Patients with known HIV infection.

5) Known history of allergy to GM-CSFor pneumococcal vaccine.

6) Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.

7) Patients who have previously received pneumococcal vaccine within the preceding 12 months.

8) Absolute lymphocyte count less than 500 cells/mm3
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Links
Registration Number: NCT00323557
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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