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

Cytokine Release Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03557749
• Other study ID #: 2017NTLS045
• Secondary ID: MT2017-12
• Status: Terminated
• Start date: September 21, 2018
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: August 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Allogenic Related Donors
• Bronchiolitis Obliterans Syndrome
• Cell Therapy/Immunotherapy Patients
• Chronic Graft-versus-host-disease
• Cytokine Release Syndrome
• Graft vs Host Disease
• Immune and Microbial Reconstitution
• Recurrent Malignancy
• Systemic Viral Infection
• Virus Diseases

Intervention

Diagnostic Test:
• Blood Sample
60 ml heparinized blood 10 ml serum
• Stool Sample
pea-sized amount
• Urine Sample
10 ml
• Bronchoalveolar Lavage (BAL) fluid
10 ml
• Gastrointestinal biopsy x 2-4
rectosigmoid site preferred
• Skin biopsy
2-4 mm punch
• Skin, mouth, and/or ocular swab
Involved skin, mouth, and/or ocular swab for microbiota studies
• Apheresis Product
Up to 10 ml of apheresis product
• 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

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Function after HCT	Incidence of neutrophil recovery	7 Years
Primary	Immune Function after HCT	Incidence of lymphocyte and monocyte subset recovery	7 Years
Primary	Immune Function after HCT	Incidence of grade II-IV acute GVHD	7 Years
Primary	Immune Function after HCT	Incidence of CMV reactivation	7 Years
Primary	Immune Function after Cell Therapy/Immunotherapy	Incidence of neutrophil recovery	7 Years
Primary	Immune Function after Cell Therapy/Immunotherapy	Incidence of lymphocyte and monocyte subset recovery	7 Years
Primary	Immune Function after Cell Therapy/Immunotherapy	Incidence of cytokine release syndrome (CRS)	7 Years
Primary	Correlate Immune Parameters	Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.	7 Years
Primary	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