Clinical trial NCT00651716: T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
Official title: Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: 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
Keywords: 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
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
recurrent mycosis fungoides/Sezary syndrome
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic neutrophilic leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
myelodysplastic/myeloproliferative neoplasm, unclassifiable
poor prognosis metastatic gestational trophoblastic tumor
previously treated myelodysplastic syndromes
recurrent neuroblastoma
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
recurrent malignant testicular germ cell tumor
secondary myelodysplastic syndromes
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage III malignant testicular germ cell tumor
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
refractory multiple myeloma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2008-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with a disease which is being treated with a bone marrow and/or a stem cell transplant.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of regulatory T-lymphocytes (Tregs) at engraftment
timeFrame: day of stem cell transplant
Secondary outcomes:
measure: Association between Treg subsets and acute graft-vs.-host disease outcomes
timeFrame: at stem cell transplant and at day 28
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Brian Engelhardt, MD
role: PRINCIPAL_INVESTIGATOR
References: