Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
18 Years
N/A
Both
Lymphoma
Trial Information
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC).
Outcome Time Frame:
2 Years
Safety Issue:
No
Principal Investigator
Richard A Zuckerman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dartmouth-Hitchcock Medical Center
Authority:
United States: Institutional Review Board
Study ID:
D0748
NCT ID:
NCT00889278
Start Date:
February 2008
Completion Date:
February 2013
Related Keywords:
- Lymphoma
- Lymphoma
- Autologous Peripheral Blood Stem Cell Transplant
- APBSCT
- Pneumococcal Conjugate Vaccine
- Lymphoma
Name | Location |
|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
