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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Breast Cancer; Multiple Myeloma and Plasma Cell Neoplasm; Neuroblastoma; Gestational Trophoblastic Tumor; Chronic Myeloproliferative Disorders; Lymphoma; Ovarian Cancer; Leukemia; Myelodysplastic Syndromes; Testicular Germ Cell Tumor; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Other: flow cytometry; Other: Data Collection; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00651716

P30CA068485 (U.S. NIH Grant/Contract)

VICC BMT 0653

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No 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

Trial design

150 participants in 1 patient group

Allogeneic Stem Cell Transplant Patients

Description:

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

Treatment:

Other: Data Collection

Other: laboratory biomarker analysis

Other: flow cytometry