Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| 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 ]
| Enrollment: | 60 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing allogeneic hematopoietic stem cell transplantation at the City of Hope Medical Center
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | David Senitzer, PhD | Beckman Research Institute |
More Information
No publications provided
| Responsible Party: | David Senitzer, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00813501 History of Changes |
| Other Study ID Numbers: | 07200, P30CA033572, CHNMC-07200, CDR0000628793 |
| Study First Received: | December 20, 2008 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
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 |
Additional relevant MeSH terms:
|
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 Immune System Diseases |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive |
ClinicalTrials.gov processed this record on May 23, 2013