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NCT Number: NCT02301065

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

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.

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Neoplasms Neoplasms by Site

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • Michigan State University

Registry information

Official study title

Analysis of KIR+CD56+ T Cells and FcRg-CD56+CD3- NK Cells in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients and Donors

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2014
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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