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

Terminated

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

• 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

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Study Start: 2018-09-21
• Primary Completion: 2023-06-30
• Status Verified: 2023-08
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (1)

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States