Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma
- Assess immune reconstitution as measured by response to pneumococcal polyvalent
vaccine, NK-cell activity against autologous lymphoblastoid cell lines, and
cytomegalovirus and Epstein-Barr virus tetramer responses in patients who have
undergone autologous hematopoietic stem cell transplantation for high-risk lymphoma or
- Assess the absolute number of circulating regulatory T-cells and the function of these
cells as measured by their expression of TGFβ and interleukin-10 (IL-10).
- Evaluate the effect of conditioning therapy on quality of life, including functional
status, fatigue, and depression, in these patients.
- Correlate quality of life with inflammatory cytokine production of peripheral blood
monocytes at specified time points.
- Provide baseline immune reconstitution and quality of life pilot data for comparison in
future post-transplant immunotherapy trials.
OUTLINE: Patients receive pneumococcal polyvalent vaccine intramuscularly once in weeks 9,
17, and 25 after autologous hematopoietic stem cell transplantation.
Blood samples are collected periodically for correlative and immunological studies.
Quality of life (QOL) is assessed periodically using the QOL short form (SF-36, 4-week
version), the Center for Epidemiologic Studies Depression scale (CES-D), and the
Multidimensional Fatigue Symptom Inventory (MFSI-30).
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Craig C. Hofmeister, MD
Ohio State University Comprehensive Cancer Center
United States: Food and Drug Administration
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|