Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
- Conditions
- Immune and Microbial ReconstitutionRecurrent MalignancyCytokine Release SyndromeCell Therapy/Immunotherapy PatientsSystemic Viral InfectionChronic Graft-versus-host-diseaseAllogenic Related DonorsAcute-graft-versus-host Disease
- Interventions
- Diagnostic Test: Blood SampleDiagnostic Test: Apheresis ProductDiagnostic Test: Skin biopsyDiagnostic Test: Final cellular productDiagnostic Test: Stool SampleDiagnostic Test: Bronchoalveolar Lavage (BAL) fluidDiagnostic Test: Skin, mouth, and/or ocular swabDiagnostic Test: Urine SampleDiagnostic Test: Gastrointestinal biopsy x 2-4
- Registration Number
- NCT03557749
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief Summary
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 210
- Patients planning to undergo HCT or other cellular therapy/immunotherapy
- Allogeneic related donors
- Aged 0-80
- Willing and able to sign voluntary written consent
- Patients whose medical record indicates that they have opted out of research
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Immune Response Triggered by Chronic Graft-versus-Host Disease Skin biopsy - Cellular Therapy Products Final cellular product - Immune Response Triggered by Acute Graft-versus-Host Disease Stool Sample - Immune Response Triggered by Chronic Graft-versus-Host Disease Blood Sample - Immune Response Triggered by Chronic Graft-versus-Host Disease Skin, mouth, and/or ocular swab - Immune Response Triggered by Cytokine Release Syndrome Blood Sample - Cellular Therapy Products Apheresis Product - Immune and Microbial Reconstitution Stool Sample - Immune Response Triggered by Severe, Systemic Viral Infection Blood Sample - Immune Response Triggered by Severe, Systemic Viral Infection Bronchoalveolar Lavage (BAL) fluid - Immune Response Triggered by Acute Graft-versus-Host Disease Blood Sample - Allogeneic Related Donor Samples Stool Sample - Allogeneic Related Donor Samples Urine Sample - Immune and Microbial Reconstitution Blood Sample - Immune and Microbial Reconstitution Urine Sample - Immune Response Triggered by Acute Graft-versus-Host Disease Gastrointestinal biopsy x 2-4 - Immune Response Triggered by Acute Graft-versus-Host Disease Skin biopsy - Immune Response Triggered by Relapse Blood Sample - Allogeneic Related Donor Samples Blood Sample -
- Primary Outcome Measures
Name Time Method Immune Function after HCT 7 Years Incidence of CMV reactivation
Immune Function after Cell Therapy/Immunotherapy 7 Years Incidence of cytokine release syndrome (CRS)
Correlate microbiota changes and their interactions with the host with outcomes of HCT 7 Years Correlate microbiota changes and their interactions with the host with outcomes of HCT
Correlate Immune Parameters 7 Years Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States