Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Multiple Myeloma, Primary Mediastinal Large B-Cell Lymphoma, Small Lymphocytic Lymphoma
Conditions
Brief summary
This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.
Detailed description
PRIMARY OBJECTIVES: I. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy. II. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level. OUTLINE: This is an observational study. Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \* Willingness to provide written informed consent before any study-specific procedures or activities are performed * Age ≥ 18 years of age, at the time of consent * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed * History of prior vaccination against common VPD * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus
Exclusion criteria
* \* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preserved immunity | Up to 12 months after CAR-T cell infusion | Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in antibody titers | At baseline, at 6 months and at 1 year after vaccination | Immune reconstitution will be reported based on ELISA assays for S. pneumoniae or tetanus after each dose of respective vaccine for the re-vaccination populations. Will be correlated with the changes of CD4+ and IgG using a Spearman correlation coefficient. |
Countries
United States
Outcome results
None listed