Status:
COMPLETED
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
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...
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). Infecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 5 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00889278
Start Date
February 1 2008
End Date
January 5 2016
Last Update
May 22 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756