Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00569309|
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
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||Phase|
|Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Small Intestine Cancer||Biological: Streptococcus pneumoniae Other: laboratory correlative studies Other: quality-of-life assessment||Not Applicable|
- 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 :||30 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|
|Actual Study Start Date :||December 12, 2007|
|Actual Primary Completion Date :||July 29, 2011|
|Actual Study Completion Date :||July 29, 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
- Number of Participants Experiencing Immune Reconstitution [ Time Frame: Up to 2 years ]Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma
- 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 ]
- Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes [ Time Frame: Up to 3 years ]
- Quality of Life, Including Brief Pain Inventory [ Time Frame: Up to 3 years ]The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
- Quality of Life, Including Fatigue [ Time Frame: Up to 3 years ]Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
- 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|