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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00651716
First received: April 2, 2008
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Anaplastic Plasmacytoma B-cell Lymphomas Burkitt Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Follicular Lymphoma Gestational Trophoblastic Tumor Hairy Cell Leukemia Hodgkin Lymphoma Homologous Wasting Disease Hydatidiform Mole Hypereosinophilic Syndrome Leukemia, B-cell, Chronic Leukemia, Myeloid Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Neuroblastoma Neuroepithelioma Ovarian Cancer Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Plasmablastic Lymphoma Sezary Syndrome Testicular Cancer
U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Percentage of regulatory T-lymphocytes (Tregs) at engraftment [ Time Frame: day of stem cell transplant ] [ Designated as safety issue: No ]
    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 [ Time Frame: at stem cell transplant and at day 28 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 200
Study Start Date: December 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

People with a disease which is being treated with a bone marrow and/or a stem cell transplant.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651716

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Brian Engelhardt, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Brian Engelhardt, MD, Assistant Professor of Medicine; Hematologist/Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00651716     History of Changes
Other Study ID Numbers: VICC BMT 0653, P30CA068485
Study First Received: April 2, 2008
Last Updated: June 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Breast Neoplasms
Gestational Trophoblastic Disease
Graft vs Host Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Plasma Cell
Neuroblastoma
Ovarian Neoplasms
Plasmacytoma
Preleukemia
Syndrome
Testicular Neoplasms
Trophoblastic Neoplasms
Adnexal Diseases
Blood Protein Disorders
Bone Marrow Diseases
Breast Diseases
Cardiovascular Diseases
Disease
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on November 25, 2014