Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
Official Title
Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation
Acronym
Not provided
Organization
City of Hope Medical CenterOTHER
Status Module
Record Verification Date
Mar 2011
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Terminated at the request of the study sponsor
Expanded Access Info
No
Start Date
Jun 2008
Primary Completion Date
Jun 2010Actual
Completion Date
Jun 2010Actual
First Submitted Date
Dec 20, 2008
First Submission Date that Met QC Criteria
Dec 20, 2008
First Posted Date
Dec 23, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 3, 2011
Last Update Posted Date
Mar 7, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
City of Hope Medical CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
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.
Conditions Module
Conditions
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
Keywords
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