NCT00569309

Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma

Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer cells that remain after transplant. PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients who have undergone autologous stem cell transplant for high-risk lymphoma or multiple myeloma.

Detailed description

OBJECTIVES: Primary * 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 multiple myeloma. Secondary * 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).

Conditions

• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Small Intestine Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Streptococcus pneumoniae	Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
OTHER	laboratory correlative studies	Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
OTHER	quality-of-life assessment	Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.

Timeline

• Start date: 2007-12-12
• Primary completion: 2011-07-29
• Completion: 2011-07-29
• First posted: 2007-12-07
• Last updated: 2018-03-12
• Results posted: 2018-03-12

Locations

1 site across 1 country: United States