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Analysis of T Cell and Natural Killer (NK) Cell in Relation to Viral Infections in Pediatric Stem Cell Transplant Patients and Donors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301065
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date November 18, 2014
First Posted Date November 25, 2014
Last Update Posted Date July 17, 2017
Actual Study Start Date October 13, 2016
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2014)
  • Percentage of KIR+CD45+ T-cells in stem cell recipients and donors [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 2 weeks, up to 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have a blood sample drawn once within 1 week prior to stem cell donation.
    • HSCT recipients will have serial blood samples: a baseline sample within 1 week prior to stem cell infusion and collections every 2 weeks, up to 100 days post-transplantation
    Summary statistics of the two cell populations, such as mean, median, range, and standard error, will be provided.
  • Number of FcRg-CD56+CD3- NK cells in stem cell recipients and donors [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 2 weeks, up to 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have a blood sample drawn once within 1 week prior to stem cell donation.
    • HSCT recipients will have serial blood samples: a baseline sample within 1 week prior to stem cell infusion and collections every 2 weeks, up to 100 days post-transplantation
    Summary statistics of the two cell populations, such as mean, median, range, and standard error, will be provided.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2014)
  • Surface marker expression density of phenotype KIR+CD56+ T-cells and FcRg-CD56+CD3- NK cells in donors and recipients [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: within 1 week prior to stem cell infusion and within 1 week of 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have a blood sample drawn once within 1 week prior to stem cell donation.
    • HSCT recipients will have two blood samples drawn: the first within 1 week prior to stem cell infusion, and the second within 1 week of 100 days post-transplantation
    Surface marker expression density will be calculated and summary statistics will be provided for all calculations.
  • Percentage of KIR+CD56+ T-cells that stain for tetramer/pentamer [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 28 days, up to 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have percentages measured once within 1 week prior to stem cell donation.
    • HSCT recipients will have serial blood samples, a baseline sample within 1 week prior to stem cell infusion, and collections every 28 days, up to 100 days post-transplantation
    The specificity of KIR+CD56+T-cells will be evaluated through viral tetramer/pentamer staining.
  • Change in numbers and percentages of KIR+CD56+T-cells after exposure to viral antigen in vitro and cytokine expression levels [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 28 days, up to 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have a blood sample drawn once within 1 week prior to stem cell donation.
    • HSCT recipients will have serial blood samples, including a baseline sample within 1 week prior to stem cell infusion and collections every 28 days, up to 100 days post-transplantation
    The functional capacity of KIR+CD56+T-cells will be evaluated through proliferation and cytokine production assays. Summary statistics will be provided.
  • Number of FcRg-CD56+CD3- NK cells after exposure to cytomegalovirus [ Time Frame: Donors once within 1 week prior to stem cell donation. HSCT recipients: within 1 week prior to stem cell infusion and within 1 week of 100 days post-transplantation ]
    Blood samples will be drawn as follows:
    • Donors will have will have one blood sample drawn within 1 week prior to stem cell donation.
    • HSCT recipients will have two blood samples drawn: the first within 1 week prior to stem cell infusion, and the second within 1 week of 100 days post-transplantation
    Summary statistics of the functional capacity of FcRg-CD56+CD3- NK against CMV-infected cells will be provided.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of T Cell and Natural Killer (NK) Cell in Relation to Viral Infections in Pediatric Stem Cell Transplant Patients and Donors
Official Title Analysis of KIR+CD56+ T Cells and FcRg-CD56+CD3- NK Cells in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients and Donors
Brief Summary

Viral infections and reactivation during pediatric allogeneic hematopoietic stem cell transplantation (HSCT) are a common occurrence and significantly contribute to post-transplant morbidity and mortality. The risk is high due to prolonged periods of immune deficiency while awaiting immune reconstitution post-transplant. Current strategies to reduce complications from viral infections include prophylactic treatment, close monitoring for viral infections and prompt treatment at the first sign of symptoms or increasing viral load. However, the most definitive treatment for viral infections remains the host's cellular defenses. Improved understanding of the immune systems response to viral infections may lead to better treatment strategies.

This study is being done to explore the relationships between T-cells and NK cells (infection fighting cells) and viral infections or reactivations in young allogeneic stem cell transplant patients. The investigators will be looking at how these cells react and function in young patients receiving allogeneic stem cell transplantation, as well as in healthy stem cell donors.

Detailed Description

PRIMARY OBJECTIVE:

  • To explore the expansion patterns of KIR+CD56+ T-cells and FcRg-CD56+CD3- NK cells in response to viral infection and reactivation in pediatric allogeneic hematopoietic stem cell transplant (HSCT) patients.

SECONDARY OBJECTIVES:

  • To describe the phenotype of KIR+CD56+ T-cells and FcRg-CD56+CD3- NK cells in pediatric allogeneic HSCT patients and healthy donors.
  • To describe the specificity and functional capacity of KIR+CD56+ T-cells against viral antigens in both pediatric allogeneic HSCT patients and healthy donors.
  • To describe the functional capacity of FcRg-CD56+CD3- NK cells against CMV-infected cells in both pediatric allogeneic HSCT patients and healthy donors.
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 The study is planned to enroll 50 pediatric allogeneic hematopoietic stem cell transplant (HSCT) patients and 50 donors. All patients/donors who meet eligibility criteria and sign the consent form will be enrolled on the study.
Condition Hematologic Malignancies
Intervention Not Provided
Study Groups/Cohorts
  • Stem Cell Donors
    Allogeneic hematopoietic stem cell transplant (HSCT) donors. Blood samples for phenotypes research will be collected once from donors, prior to apheresis for collection of donor stem cells.
  • Stem Cell Recipients
    Allogeneic hematopoietic stem cell transplant (HSCT) recipients. Blood samples will be drawn prior to transplantation and every two weeks, up to day 100 post-transplantation.
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 Completed
Actual Enrollment
 (submitted: July 14, 2017)
35
Original Estimated Enrollment
 (submitted: November 21, 2014)
100
Actual Study Completion Date February 6, 2017
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) for a hematologic malignancy or a donor for a patient undergoing allogeneic hematopoietic stem cell transplant for a hematologic malignancy.
  • For HSCT patients: ages birth to 21 years old; for donors: any age.
  • For minors less than 18 years old, both parents must be available on St. Jude campus to provide consent. One parent/legal guardian will be acceptable if one parent is deceased, incompetent, or when the one parent present has legal responsibility for the care and custody of the child.

Exclusion Criteria:

  • Patients undergoing allogeneic hematopoietic stem cell transplant for a disease other than a hematologic malignancy
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02301065
Other Study ID Numbers KIRT
Has Data Monitoring Committee No
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 St. Jude Children's Research Hospital
Study Sponsor St. Jude Children's Research Hospital
Collaborators Michigan State University
Investigators
Principal Investigator: Aimee Talleur, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date July 2017