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

University of Minnesota (UMN)

Status: Terminated

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT03557749

MT2017-12 (Other Identifier)

2017NTLS045

Details and patient eligibility

About

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).

Enrollment: 210 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 8 patient groups

Immune and Microbial Reconstitution

Treatment:

Diagnostic Test: Stool Sample

Diagnostic Test: Urine Sample

Diagnostic Test: Blood Sample

Immune Response Triggered by Severe, Systemic Viral Infection

Treatment:

Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid

Diagnostic Test: Blood Sample

Immune Response Triggered by Acute Graft-versus-Host Disease

Treatment:

Diagnostic Test: Skin biopsy

Diagnostic Test: Gastrointestinal biopsy x 2-4

Diagnostic Test: Stool Sample

Diagnostic Test: Blood Sample

Immune Response Triggered by Chronic Graft-versus-Host Disease

Treatment:

Diagnostic Test: Skin biopsy

Diagnostic Test: Skin, mouth, and/or ocular swab

Diagnostic Test: Blood Sample

Immune Response Triggered by Relapse

Treatment:

Diagnostic Test: Blood Sample

Immune Response Triggered by Cytokine Release Syndrome

Treatment:

Diagnostic Test: Blood Sample

Allogeneic Related Donor Samples

Treatment:

Diagnostic Test: Stool Sample

Diagnostic Test: Urine Sample

Diagnostic Test: Blood Sample

Cellular Therapy Products

Treatment:

Diagnostic Test: Apheresis Product

Diagnostic Test: Final cellular product