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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

May 5, 2006
December 3, 2012
June 2004
May 2011   (final data collection date for primary outcome measure)
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine [ Time Frame: Baseline and at 1 month after vaccine. ] [ Designated as safety issue: No ]
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.
  • Anti-pneumococcal IgG serum level > 250 mg of antibody nitrogen/ml will be
  • considered protective. Measurement of antibody response will include either
  • radioimmunoassay or serotype-specific antibodies by enzyme-linked immunosorbent
  • assay. The antibody levels will be checked on the day of vaccination; one and
  • 3 months after vaccination is given.
Complete list of historical versions of study NCT00323557 on ClinicalTrials.gov Archive Site
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Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • 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.
    Other Names:
    • Leukine
    • GM-CSF
    • Granulocyte macrophage colony stimulating factor -
  • Biological: Pneumococcal Vaccine
    Subcutaneously on Day 0
    Other Name: Prevnar
  • Experimental: 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.
    Intervention: Drug: Sargramostim (GM-CSF)
  • Experimental: Pneumococcal Vaccine Alone
    First vaccine dose subcutaneously, Day 0.
    Intervention: Biological: Pneumococcal Vaccine
Safdar A, Rodriguez GH, Rueda AM, Wierda WG, Ferrajoli A, Musher DM, O'Brien S, Koller CA, Bodey GP, Keating MJ. Multiple-dose granulocyte-macrophage-colony-stimulating factor plus 23-valent polysaccharide pneumococcal vaccine in patients with chronic lymphocytic leukemia: a prospective, randomized trial of safety and immunogenicity. Cancer. 2008 Jul 15;113(2):383-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

1) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (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 (Temperature > 38 degrees C) within 1 week.
  3. Active infection.
  4. Patients with known Human immunodeficiency virus (HIV) infection.
  5. Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or 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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00323557
2003-0605
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Bayer
Principal Investigator: Amar Safdar, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP