Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
|ClinicalTrials.gov Identifier: NCT00813501|
Recruitment Status : Terminated (Terminated at the request of the study sponsor)
First Posted : December 23, 2008
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment|
|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||Biological: immunosuppressive therapy Other: immunological diagnostic method Procedure: allogeneic hematopoietic stem cell transplantation|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813501
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||David Senitzer, PhD||City of Hope Comprehensive Cancer Center|