Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation
18 Years
65 Years
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Neuroblastoma, Therapy-related Toxicity
Trial Information
Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation
OBJECTIVES:
- To evaluate the ability of the ImmuKnow® test to predict the onset and severity of
acute or chronic graft-versus-host disease and/or measure the clinical effects of
treatment.
- To evaluate the ability of the ImmuKnow test to predict the clinical response to
immunosuppressive therapy.
- To evaluate the ability of the ImmuKnow test to predict infections among patients.
OUTLINE: Beginning on day 14 after allogeneic hematopoietic stem cell transplantation
(HSCT), patients undergo blood sample collection at least once weekly for the first 100 days
and then once to twice monthly for up to 1 year, in the absence of graft-versus-host disease
(GVHD). If chronic or acute GVHD develops after day 100, more frequent blood sampling may
occur. Blood sample collection is coordinated with the time of regular clinic visits to
allow for evaluation of the clinical events recorded 2 weeks before and after the blood draw
date. Blood samples are analyzed by the Cylex® and ImmuKnow® assays to measure global T-cell
immune function and responsiveness to alterations in immunosuppressive post-HSCT therapy.
Assay data obtained during the first 3 weeks and other post-transplant periods will be
evaluated for possible correlations with clinical endpoints (i.e., GVHD incidence, rate of
infection, and response to immunosuppressive therapy) to assess the predictive value of the
assay.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Acute graft-versus-host disease (GVHD)
Safety Issue:
No
Principal Investigator
David Senitzer, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
07200
NCT ID:
NCT00813501
Start Date:
June 2008
Completion Date:
June 2010
Related Keywords:
- Chronic Myeloproliferative Disorders
- Graft Versus Host Disease
- Infection
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic-Myeloproliferative Diseases
- Neuroblastoma
- Therapy-related Toxicity
- graft versus host disease
- infection
- therapy-related toxicity
- 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
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Neuroblastoma
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
