Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies

Study Overview
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Brief Summary
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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).

Official Title
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Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies

Conditions
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Immune and Microbial Reconstitution, Systemic Viral Infection, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Recurrent Malignancy, Cytokine Release Syndrome, Allogenic Related Donors, Cell Therapy/Immunotherapy Patients

Intervention / Treatment
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* Diagnostic Test: Blood Sample
* Diagnostic Test: Stool Sample
* Diagnostic Test: Urine Sample
* Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid
* Diagnostic Test: Gastrointestinal biopsy x 2-4
* Diagnostic Test: Skin biopsy
* Diagnostic Test: Skin, mouth, and/or ocular swab
* Diagnostic Test: Apheresis Product
* Diagnostic Test: Final cellular product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planning to undergo HCT or other cellular therapy/immunotherapy Allogeneic related donors Aged 0-80 Willing and able to sign voluntary written consent Exclusion Criteria: Patients whose medical record indicates that they have opted out of research
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immune and Microbial Reconstitution<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>Diagnostic Test: Stool Sample<br>* pea-sized amount<br>Diagnostic Test: Urine Sample<br>* 10 ml<br>|
| Immune Response Triggered by Severe, Systemic Viral Infection<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid<br>* 10 ml<br>|
| Immune Response Triggered by Acute Graft-versus-Host Disease<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>Diagnostic Test: Stool Sample<br>* pea-sized amount<br>Diagnostic Test: Gastrointestinal biopsy x 2-4<br>* rectosigmoid site preferred<br>Diagnostic Test: Skin biopsy<br>* 2-4 mm punch<br>|
| Immune Response Triggered by Chronic Graft-versus-Host Disease<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>Diagnostic Test: Skin biopsy<br>* 2-4 mm punch<br>Diagnostic Test: Skin, mouth, and/or ocular swab<br>* Involved skin, mouth, and/or ocular swab for microbiota studies<br>|
| Immune Response Triggered by Relapse<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>|
| Immune Response Triggered by Cytokine Release Syndrome<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>|
| Allogeneic Related Donor Samples<br> | Diagnostic Test: Blood Sample<br>* 60 ml heparinized blood 10 ml serum<br>Diagnostic Test: Stool Sample<br>* pea-sized amount<br>Diagnostic Test: Urine Sample<br>* 10 ml<br>|
| Cellular Therapy Products<br> | Diagnostic Test: Apheresis Product<br>* Up to 10 ml of apheresis product<br>Diagnostic Test: Final cellular product<br>* A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Function after HCT | Incidence of neutrophil recovery | 7 Years | 
| Immune Function after HCT | Incidence of lymphocyte and monocyte subset recovery | 7 Years | 
| Immune Function after HCT | Incidence of grade II-IV acute GVHD | 7 Years | 
| Immune Function after HCT | Incidence of CMV reactivation | 7 Years | 
| Immune Function after Cell Therapy/Immunotherapy | Incidence of neutrophil recovery | 7 Years | 
| Immune Function after Cell Therapy/Immunotherapy | Incidence of lymphocyte and monocyte subset recovery | 7 Years | 
| Immune Function after Cell Therapy/Immunotherapy | Incidence of cytokine release syndrome (CRS) | 7 Years | 
| Correlate Immune Parameters | Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen. | 7 Years | 
| Correlate microbiota changes and their interactions with the host with outcomes of HCT | Correlate microbiota changes and their interactions with the host with outcomes of HCT | 7 Years |