T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict whether patients undergoing donor stem cell transplant will develop acute graft-versus-host disease.

PURPOSE: This clinical trial is studying T cells to see how well they help in predicting acute graft-versus-host disease in patients undergoing donor stem cell transplant.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor	Other: flow cytometry Other: laboratory biomarker analysis Other: Data Collection

Detailed Description

OBJECTIVES:

To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 28 with the incidence of acute graft-versus-host-disease (aGVHD) in patients undergoing allogeneic stem cell transplantation.
To identify gut-homing and skin-homing Treg subsets and determine their role during engraftment and at day 28 as a predictor of gut and skin aGVHD, respectively.

OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment prior to stem cell transplant (SCT) and post-SCT on days 7, 14, 21, and 28 days after allogeneic stem cell transplantation. Blood samples are analyzed for T-cell subsets and for the percentage of regulatory T-lymphocyte (Treg) or other T-cell subsets expressing specific homing receptors for the gut or skin via flow cytometry.

Patients' medical records are also reviewed periodically.

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Allogeneic Stem Cell Transplant Patients Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.	Other: flow cytometry Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry. Other: laboratory biomarker analysis Identification of gut-homing and skin-homing Treg subsets Other: Data Collection Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.

Arm

Intervention/Treatment

Allogeneic Stem Cell Transplant Patients

Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.

Other: flow cytometry

Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry.

Other: laboratory biomarker analysis

Identification of gut-homing and skin-homing Treg subsets

Other: Data Collection

Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.

Outcome Measures

Primary Outcome Measures

Percentage of regulatory T-lymphocytes (Tregs) at engraftment [day of stem cell transplant]
percentage of Treg subsets present in patient's blood before they undergo stem cell transplant

Secondary Outcome Measures

Association between Treg subsets and acute graft-vs.-host disease outcomes [at stem cell transplant and at day 28]
Identify gut homing and skin homing Treg lymphocyte subsets and compare and contrast them to determine links between the Treg subsets and gut and/or skin acute graft-vs.-host-disease incidence, stage/grade, target organ involvement, and responsiveness to therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Patients undergoing allogeneic SCT
Age >= 18 years

Exclusion criteria:

Inability to give informed consent
Patients who have not received an allogeneic SCT
Any condition which, in the opinion of the investigator, might interfere with study objective
Any reason which, in the opinion of the investigator, adds additional risk to the patient