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

NCT00323557 | Completed Phase 2 Results

• 1 other identifier: 2003-0605
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Leukemia

Keywords

Chronic Lymphocytic Leukemia; Leukemia; Sargramostim; Pneumococcal Pneumonia; Pneumococcal Vaccine; Prevnar; GM-CSF; CLL

Outcome Measures

Primary Outcomes (1)

• Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal 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.

  Baseline and at 1 month after vaccine.

Study Arms (2)

Pneumococcal Vaccine + GM-CSF

EXPERIMENTAL

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.

Drug: Sargramostim (GM-CSF)

Pneumococcal Vaccine Alone

EXPERIMENTAL

First vaccine dose subcutaneously, Day 0.

Biological: Pneumococcal Vaccine

Interventions

Sargramostim (GM-CSF) DRUG

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.

Also known as: Leukine, GM-CSF, Granulocyte macrophage colony stimulating factor -

Pneumococcal Vaccine + GM-CSF

Pneumococcal Vaccine BIOLOGICAL

Subcutaneously on Day 0

Also known as: Prevnar

Pneumococcal Vaccine Alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.

You may not qualify if:

• Patients will not be entered while neutropenic (PMNs \< 500 cells/mm3) or having received Rituximab within 6 months.
• Patients will not be entered while febrile (Temperature \> 38 degrees C) within 1 week.
• Active infection.
• Patients with known Human immunodeficiency virus (HIV) infection.
• Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine.
• Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.
• Patients who have previously received pneumococcal vaccine within the preceding 12 months.
• Absolute lymphocyte count less than 500 cells/mm3.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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. doi: 10.1002/cncr.23561.

  PMID: 18470901 DERIVED

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Pneumonia, Pneumococcal

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Amar Safdar, MD/Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Amar Safdar, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: June 1, 2004
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 5, 2012
• Results First Posted: May 2, 2012

Record last verified: 2012-12

Locations

US (1)