Hematologic Malignancy
Conditions
Keywords
CAR-T
Brief summary
The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of Myeloid derived suppressor cells (MDSCs) over time in patients receiving Chimeric antigen receptor (CAR) T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy.
Detailed description
The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of MDSCs over time in patients receiving CAR T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy. Blood samples and accompanying health information (including PHI) may be collected from standard of care, non-significant risk, research-only procedures or obtained from our Division Research Repository and Database (Duke IRB Pro00006268) or DUHS Biospecimen Research and Biobanking protocol (Duke IRB Pro00035974). All hematologic malignancy patients treated with commercial CAR T products will be screened and enrolled for the study. The investigators will perform multivariable regression to see if the number and function of MDSCs can be used as independent factors to predict disease relapse at 1 year after CAR T treatment, overall survival or progression-free survival. The studies will not require additional invasive procedure solely for the study. The investigators will use blood samples that are performed as part of standard care. Therefore, no additional procedure is needed. The major potential risk associated with the study is the breach of confidentiality.
Interventions
GENETICBlood draw
Patients will provide a blood draw for research and repository
Sponsors
Duke University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines. 2. Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR T therapy with commercial CAR T product. 3. Patient who has a confirmed diagnosis of hematologic malignancy and will be receiving CAR T therapy under clinical trial protocol will also be eligible if the clinical trial sponsor and the investigator approve patient participation in the study.
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between change in immune profile and disease relapse/resistance in CAR T therapy | before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years) | multivariable regression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between change in molecular/genetic analysis and disease relapse/resistance in CAR T therapy | before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years) | bulk RNA-sequencing, single cell RNA sequencing, single cell ATAC seq or metabolomics on peripheral blood samples |
| Correlation between changes in cytokine and molecular pathway profiling with disease relapse/resistance in CAR T therapy | before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years) | Cytokine profiling and molecular/genetic correlation with disease relapse/resistance in CAR T therapy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYubin Kang
Duke University
Outcome results
None listed