Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
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.
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Multiple Myeloma and Plasma Cell Neoplasm
Biological: immunosuppressive therapy
Other: immunological diagnostic method
Procedure: allogeneic hematopoietic stem cell transplantation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation|
- Acute graft-versus-host disease (GVHD) [ Designated as safety issue: No ]
- Grade of acute GVHD [ Designated as safety issue: No ]
- Response criteria for treatment of acute GVHD [ Designated as safety issue: No ]
- Chronic GVHD [ Designated as safety issue: No ]
- Grade of chronic GVHD [ Designated as safety issue: No ]
- Response criteria for treatment of chronic GVHD [ Designated as safety issue: No ]
- Infections (i.e., bacterial, fungal, or viral) [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||David Senitzer, PhD||Beckman Research Institute|