Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
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|ClinicalTrials.gov Identifier: NCT00569309|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2007
Last Update Posted : October 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Small Intestine Cancer||Biological: Streptococcus pneumoniae Other: laboratory correlative studies Other: quality-of-life assessment|
- 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.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma|
|Study Start Date :||December 2007|
|Primary Completion Date :||July 2011|
The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.
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 Names:Other: laboratory correlative studies
Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
Other Names: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.
Other Name: QOL
- Immune reconstitution [ Time Frame: Up to 3 years ]
- Serial assessment of 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) [ Time Frame: Up to 3 years ]
- Quality of life, including functional status, fatigue, and depression [ Time Frame: Up to 3 years ]
- Correlation of quality of life with inflammatory cytokine production of peripheral blood monocytes [ Time Frame: Up to 3 years ]
- Collection of baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569309
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Craig C. Hofmeister, MD||Ohio State University Comprehensive Cancer Center|