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

NCT02301065 | Completed

• 1 other identifier: KIRT
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Keywords

Viral; Infection; Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (2)

• Percentage of KIR+CD45+ T-cells in stem cell recipients and donors

  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.

  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

• Number of FcRg-CD56+CD3- NK cells in stem cell recipients and donors

  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.

  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

Secondary Outcomes (4)

• Surface marker expression density of phenotype KIR+CD56+ T-cells and FcRg-CD56+CD3- NK cells in donors and recipients

  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

• Percentage of KIR+CD56+ T-cells that stain for tetramer/pentamer

  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

• Change in numbers and percentages of KIR+CD56+T-cells after exposure to viral antigen in vitro and cytokine expression levels

  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

• Number of FcRg-CD56+CD3- NK cells after exposure to cytomegalovirus

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients undergoing allogeneic hematopoietic stem cell transplant for a disease other than a hematologic malignancy

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Michigan State University: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Hematologic Neoplasms; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Aimee Talleur, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 25, 2014
• Study Start: October 13, 2016
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Locations

US (1)