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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889278
• Other study ID #: D0748
• Status: Completed
• Start date: February 2008
• Est. completion date: January 5, 2016

Study information

• Verified date: May 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 5, 2016
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response to vaccination	To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC).	2 Years