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

Terminated

• Conditions: Testicular Germ Cell Tumor; Breast Cancer; Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Neuroblastoma; Ovarian Cancer; Multiple Myeloma and Plasma Cell Neoplasm; Gestational Trophoblastic Tumor; Myelodysplastic Syndromes
• Interventions: Other: flow cytometry; Other: laboratory biomarker analysis; Other: Data Collection

• Registration Number: NCT00651716
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allogeneic Stem Cell Transplant Patients	Data Collection	Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.
Allogeneic Stem Cell Transplant Patients	flow cytometry	Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.
Allogeneic Stem Cell Transplant Patients	laboratory biomarker analysis	Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States