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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 15, 2018
First Posted Date June 15, 2018
Last Update Posted Date September 26, 2019
Actual Study Start Date September 21, 2018
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2018)
  • Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of neutrophil recovery
  • Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of lymphocyte and monocyte subset recovery
  • Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of grade II-IV acute GVHD
  • Immune Function after HCT [ Time Frame: 7 Years ]
    Incidence of CMV reactivation
  • Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of neutrophil recovery
  • Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of lymphocyte and monocyte subset recovery
  • Immune Function after Cell Therapy/Immunotherapy [ Time Frame: 7 Years ]
    Incidence of cytokine release syndrome (CRS)
  • Correlate Immune Parameters [ Time Frame: 7 Years ]
    Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03557749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
Official Title Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program
Condition
  • 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
Intervention
  • Diagnostic Test: Blood Sample
    60 ml heparinized blood 10 ml serum
  • Diagnostic Test: Stool Sample
    pea-sized amount
  • Diagnostic Test: Urine Sample
    10 ml
  • Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid
    10 ml
  • Diagnostic Test: Gastrointestinal biopsy x 2-4
    rectosigmoid site preferred
  • 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
  • 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
Study Groups/Cohorts
  • Immune and Microbial Reconstitution
    Interventions:
    • Diagnostic Test: Blood Sample
    • Diagnostic Test: Stool Sample
    • Diagnostic Test: Urine Sample
  • Immune Response Triggered by Severe, Systemic Viral Infection
    Interventions:
    • Diagnostic Test: Blood Sample
    • Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid
  • Immune Response Triggered by Acute Graft-versus-Host Disease
    Interventions:
    • Diagnostic Test: Blood Sample
    • Diagnostic Test: Stool Sample
    • Diagnostic Test: Gastrointestinal biopsy x 2-4
    • Diagnostic Test: Skin biopsy
  • Immune Response Triggered by Chronic Graft-versus-Host Disease
    Interventions:
    • Diagnostic Test: Blood Sample
    • Diagnostic Test: Skin biopsy
    • Diagnostic Test: Skin, mouth, and/or ocular swab
  • Immune Response Triggered by Relapse
    Intervention: Diagnostic Test: Blood Sample
  • Immune Response Triggered by Cytokine Release Syndrome
    Intervention: Diagnostic Test: Blood Sample
  • Allogeneic Related Donor Samples
    Interventions:
    • Diagnostic Test: Blood Sample
    • Diagnostic Test: Stool Sample
    • Diagnostic Test: Urine Sample
  • Cellular Therapy Products
    Interventions:
    • Diagnostic Test: Apheresis Product
    • Diagnostic Test: Final cellular product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2018)
1600
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Timothy Krepsky, RN 612-273-2800 tkrepsk1@fairview.rog
Contact: Shernan Holtan, MD 612-301-1095 sgholtan@umn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03557749
Other Study ID Numbers 2017NTLS045
MT2017-12 ( Other Identifier: Masonic Cancer Center, University of Minnesota )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor Masonic Cancer Center, University of Minnesota
Collaborators Not Provided
Investigators Not Provided
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date September 2019