Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant
- To describe the immune reconstitution of T cell-, B cell- and natural killer (NK) cell-
compartment in patients undergoing autologous stem cell transplant as part of their
treatment for a malignancy.
The design for this study will be a prospective, longitudinal observational study. Immune
reconstitution will be measured in the course of autologous stem cell transplant using
serial blood samples analyzed for cell counts, immune cell phenotyping (demonstrating the
expression of specific receptors on the cell surface) and functional lymphocyte assays.
These blood samples will be obtained once prior and at defined time points after stem cell
infusion either while the research participant is hospitalized or during the scheduled
Immune recovery from conventional chemotherapy will be measured using serial blood samples
analyzed for cell counts, immune cell phenotyping, and NK cell functional assays. These
blood samples will be obtained once prior and at defined time points after completion of
courses #1 and #4 of Induction chemotherapy while the research participant is hospitalized
or during the scheduled clinic visit.
Observational Model: Case-Only, Time Perspective: Prospective
Change in the immune reconstitution of T cell, B cell, and NK cell compartment.
The order and magnitude of recovery of the different subtypes of leukocytes will be summarized by descriptive statistics. The pattern of immune reconstitution will be evaluated using longitudinal approaches such as Mixed effect models or GEE approach and implement in SAS 9.2 using PROC MIXED or PROC GENMOD. In addition, NK cell number, receptor and ligand genotype and phenotype and functional capacity will be compared at specific time points (28 days, 8 weeks and 6 months post autologous transplant) to the baseline values using paired one sample signed rank test.
Days 0, 14, 21, 28, week 8, and months 3, 6, 12, and 18 related to stem cell infusion.
Susanne Wendt, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|