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

May 18, 2018 updated by: Richard Zuckerman, Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Completed

Conditions

Lymphoma

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lymphoma patients of Dartmouth Hitchcock Medical Center's Norris Cotton Cancer Center schedule to receive APBSCT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody response to vaccination Time Frame: 2 Years	To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC).	2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

January 5, 2016

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria