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

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

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

• Study Contact: Name: Timothy Krepsky, RN; Phone Number: 612-273-2800; Email: tkrepsk1@fairview.rog
• Study Contact Backup: Name: Shernan Holtan, MD; Phone Number: 612-301-1095; Email: sgholtan@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Masonic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Bronchial Diseases; Shock; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis Obliterans; Bronchiolitis; Organizing Pneumonia; Virus Diseases; Graft vs Host Disease; Cytokine Release Syndrome; Bronchiolitis Obliterans Syndrome; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 2017NTLS045; MT2017-12 (Other Identifier: Masonic Cancer Center, University of Minnesota)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No