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

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ClinicalTrials.gov Identifier: NCT03557749
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
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 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

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030


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




Primary Outcome Measures :
  1. Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of neutrophil recovery

  2. Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of lymphocyte and monocyte subset recovery

  3. Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of grade II-IV acute GVHD

  4. Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of CMV reactivation

  5. Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of neutrophil recovery

  6. Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of lymphocyte and monocyte subset recovery

  7. Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of cytokine release syndrome (CRS)

  8. Correlate Immune Parameters [ Time Frame: 7 Years ]
    Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.

  9. Correlate microbiota changes and their interactions with the host with outcomes of HCT [ Time Frame: 7 Years ]
    Correlate microbiota changes and their interactions with the host with outcomes of HCT



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557749


Contacts
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Contact: Timothy Krepsky, RN 612-273-2800 tkrepsk1@fairview.rog
Contact: Shernan Holtan, MD 612-301-1095 sgholtan@umn.edu

Locations
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United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shernan Holtan, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota

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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03557749     History of Changes
Other Study ID Numbers: 2017NTLS045
MT2017-12 ( Other Identifier: Masonic Cancer Center, University of Minnesota )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Virus Diseases
Immune System Diseases