Clincosm LogoSign in Get a demo

Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00889278
Collaborator
(none)
30
Enrollment
1
Location
95.1
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) will lead to an improved antibody response to post-transplant immunization with Pneumococcal Conjugate Vaccine and permit effective immunization at 6 months post-transplant in lymphoma patients receiving Autologous Peripheral Blood Stem Cell Transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Infectious diseases remain a leading cause of morbidity and mortality in patients who receive high-dose chemotherapy followed by Autologous Peripheral Blood Stem Cell Transplantation (APBSCT). Infectious disease complications of transplantation might be reduced by effective post-transplant immunization but reconstitution of the immune system may take months to years after transplantation and responses to immunization are often attenuated in this setting. Correlates of improved immune reconstitution and response to immunization after transplantation would be important to identify. It has been recently shown that higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) and higher ALC at day +15 after stem cell infusion (ALC-15) are independently associated with improved overall survival after APBSCT. The mechanism of this association is unclear, but this finding suggests that improved immune responses to immunization might also be achieved with this approach making it possible to immunize at 6 months instead of at one year. This hypothesis has never been evaluated.

    Survival following APBSCT is improved with a higher A-ALC and ALC-15. It is postulated that the higher lymphocyte numbers correlate with improved immune surveillance and destruction of minimal residual disease. Thus, one must consider the probability higher A-ALC will confer improved response to T-cell dependent immunization early after transplant.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
    Actual Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Jan 5, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Antibody response to vaccination [2 Years]

      To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age or older

    • Lymphoma or lymphoproliferative disease diagnosis

    • Scheduled APBSCT

    • Able to give informed consent and comply with the procedures of the study

    • Enrollment in other interventional trials are allowed at the discretion of the investigators

    Exclusion Criteria:

    • Contraindication to Prevnar®

    • Has received immune globulin within 5 months prior to being enrolled on the study or plans to receive immune globulin prior to the day +270 (+/-30) visit

    • Currently participating in, or scheduled to participate in any clinical trial using investigational immune modulators (e.g. IL-2) at any time prior to the completion of follow-up in this study.

    • Any other underlying medical condition that, in the opinion of the investigator, may interfere with the evaluation of study objectives

    • Day +180(+/- 30days) Eligibility:

    • Has received immune globulin within the past 5 months prior to the receipt of the vaccine or plans to receive immune globulin prior to the day +270(+/- 30) visit

    • Is pregnant (as determined by urine or serum B-HCG test)

    • Participant has a contraindication to Prevnar®

    • A recent (<72 hours) febrile illness (axillary temperature >99.5°F [>37.5°C], oral temperature >100.3oF [>37.9oC], or rectal temperature >101.3°F[>38.5°C]) prior to the study vaccination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center

    Investigators

    • Principal Investigator: Richard A Zuckerman, MD, Dartmouth-Hitchcock Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Zuckerman, Director, Transplant Infectious Disease Program, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT00889278
    Other Study ID Numbers:
    • D0748
    First Posted:
    Apr 28, 2009
    Last Update Posted:
    May 22, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Richard Zuckerman, Director, Transplant Infectious Disease Program, Dartmouth-Hitchcock Medical Center
    Lymphoma
    Autologous Peripheral Blood Stem Cell Transplant
    APBSCT
    Pneumococcal Conjugate Vaccine
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of May 22, 2018