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Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant


N/A
N/A
21 Years
Open (Enrolling)
Both
Solid Tumor, Brain Tumor, Lymphoma

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Trial Information

Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant


Primary Objective:

- To describe the immune reconstitution of T cell-, B cell- and natural killer (NK) cell-
compartment in patients undergoing autologous stem cell transplant as part of their
treatment for a malignancy.

The design for this study will be a prospective, longitudinal observational study. Immune
reconstitution will be measured in the course of autologous stem cell transplant using
serial blood samples analyzed for cell counts, immune cell phenotyping (demonstrating the
expression of specific receptors on the cell surface) and functional lymphocyte assays.
These blood samples will be obtained once prior and at defined time points after stem cell
infusion either while the research participant is hospitalized or during the scheduled
clinic visit.

Immune recovery from conventional chemotherapy will be measured using serial blood samples
analyzed for cell counts, immune cell phenotyping, and NK cell functional assays. These
blood samples will be obtained once prior and at defined time points after completion of
courses #1 and #4 of Induction chemotherapy while the research participant is hospitalized
or during the scheduled clinic visit.


Inclusion Criteria:



- Patients with solid tumors, brain tumors or lymphoma regardless of previously
received cancer related therapies who are enrolled on a study protocol or treatment
plan that includes or will likely include autologous stem cell transplant.

- Patient age >0 to 21 years

Exclusion Criteria:

- Patient receiving an autologous transplant for a disease other than listed above.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Change in the immune reconstitution of T cell, B cell, and NK cell compartment.

Outcome Description:

The order and magnitude of recovery of the different subtypes of leukocytes will be summarized by descriptive statistics. The pattern of immune reconstitution will be evaluated using longitudinal approaches such as Mixed effect models or GEE approach and implement in SAS 9.2 using PROC MIXED or PROC GENMOD. In addition, NK cell number, receptor and ligand genotype and phenotype and functional capacity will be compared at specific time points (28 days, 8 weeks and 6 months post autologous transplant) to the baseline values using paired one sample signed rank test.

Outcome Time Frame:

Days 0, 14, 21, 28, week 8, and months 3, 6, 12, and 18 related to stem cell infusion.

Safety Issue:

No

Principal Investigator

Susanne Wendt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

XPD12-013 IROPAST

NCT ID:

NCT01540175

Start Date:

March 2012

Completion Date:

December 2014

Related Keywords:

  • Solid Tumor
  • Brain Tumor
  • Lymphoma
  • Autologous stem cell transplant
  • Immune reconstitution
  • Brain Neoplasms
  • Lymphoma

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794