NCT00813501

Brief Summary

RATIONALE: Studying a diagnostic biomarker test in blood samples from patients who have undergone a donor stem cell transplant for cancer may help doctors plan treatment. PURPOSE: This clinical trial is studying an immunologic diagnostic blood test to see how well it works in predicting side-effects in patients with hematologic cancer or other disorders who have undergone a donor stem cell transplant.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

2 years

First QC Date

December 20, 2008

Last Update Submit

March 3, 2011

Conditions

Chronic Myeloproliferative DisordersGraft Versus Host DiseaseInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaTherapy-related Toxicity

Keywords

graft versus host diseaseinfectiontherapy-related toxicitystage 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, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (7)

  • Acute graft-versus-host disease (GVHD)

  • Grade of acute GVHD

  • Response criteria for treatment of acute GVHD

  • Chronic GVHD

  • Grade of chronic GVHD

  • Response criteria for treatment of chronic GVHD

  • Infections (i.e., bacterial, fungal, or viral)

Interventions

immunosuppressive therapyBIOLOGICAL
immunological diagnostic methodOTHER
allogeneic hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

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

Patients undergoing allogeneic hematopoietic stem cell transplantation at the City of Hope Medical Center

DISEASE CHARACTERISTICS: * Diagnosis of a hematologic cancer or other disease * Undergoing allogeneic hematopoietic stem cell transplantation PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersGraft vs Host DiseaseInfectionsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaBurkitt 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, Chronic

Interventions

Immunosuppression Therapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor 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 Processes

Intervention Hierarchy (Ancestors)

ImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • David Senitzer, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2008

First Posted

December 23, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)