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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651716
• Other study ID #: VICC BMT 0653
• Secondary ID: P30CA068485
• Status: Terminated
• Start date: December 2006
• Est. completion date: October 2019

Study information

• Verified date: November 2019
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Myeloproliferative Disorders
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Ovarian Cancer
• Preleukemia
• Syndrome
• Testicular Germ Cell Tumor
• Trophoblastic Neoplasms

Intervention

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.
• laboratory biomarker analysis
Identification of gut-homing and skin-homing Treg subsets
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of regulatory T-lymphocytes (Tregs) at engraftment	percentage of Treg subsets present in patient's blood before they undergo stem cell transplant	day of stem cell transplant
Secondary	Association between Treg subsets and acute graft-vs.-host disease outcomes	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.	at stem cell transplant and at day 28

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial