Clinical trial NCT00889278: Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
Official title: Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
Autologous Peripheral Blood Stem Cell Transplant
APBSCT
Pneumococcal Conjugate Vaccine
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma patients of Dartmouth Hitchcock Medical Center's Norris Cotton Cancer Center schedule to receive APBSCT.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antibody response to vaccination
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard A Zuckerman, MD
role: PRINCIPAL_INVESTIGATOR
References: