Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
OBJECTIVES:
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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.
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To evaluate the ability of the ImmuKnow test to predict the clinical response to immunosuppressive therapy.
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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 Design
Outcome Measures
Primary Outcome Measures
- 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) []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of a hematologic cancer or other disease
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Undergoing allogeneic hematopoietic stem cell transplantation
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David Senitzer, PhD, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07200
- P30CA033572
- CHNMC-07200
- CDR0000628793