NCT00651716

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

12.8 years

First QC Date

April 2, 2008

Last Update Submit

November 14, 2019

Conditions

Breast CancerChronic Myeloproliferative DisordersGestational Trophoblastic TumorLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaOvarian CancerTesticular Germ Cell Tumor

Keywords

stage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent mycosis fungoides/Sezary syndromeextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomaaccelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 negativeblastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiade novo myelodysplastic syndromesdisseminated neuroblastomamyelodysplastic/myeloproliferative neoplasm, unclassifiablepoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromesrecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent malignant testicular germ cell tumorsecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomastage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerstage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Association between Treg subsets and acute graft-vs.-host disease outcomes

    at stem cell transplant and at day 28

Study Arms (1)

Allogeneic Stem Cell Transplant Patients

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

Other: flow cytometryOther: laboratory biomarker analysisOther: Data Collection

Interventions

flow cytometryOTHER

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.

Allogeneic Stem Cell Transplant Patients
laboratory biomarker analysisOTHER

Identification of gut-homing and skin-homing Treg subsets

Allogeneic Stem Cell Transplant Patients
Data CollectionOTHER

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.

Allogeneic Stem Cell Transplant Patients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients undergoing allogeneic SCT
  • Age \>= 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast NeoplasmsMyeloproliferative DisordersGestational Trophoblastic DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaOvarian NeoplasmsTesticular Germ Cell TumorBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Hairy CellPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicCarcinoma, Ovarian EpithelialTesticular Neoplasms

Interventions

Flow CytometryData Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypePregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesCarcinomaGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brian Engelhardt, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine; Hematologist/Oncologist

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 3, 2008

Study Start

December 1, 2006

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

US(1)