Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases

This study has been terminated.
(Terminated at the request of the study sponsor)
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00813501
First received: December 20, 2008
Last updated: March 3, 2011
Last verified: March 2011

December 20, 2008
March 3, 2011
June 2008
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00813501 on ClinicalTrials.gov Archive Site
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Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases
Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients undergoing allogeneic hematopoietic stem cell transplantation at the City of Hope Medical Center

  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00813501
07200, P30CA033572, CHNMC-07200, CDR0000628793
Yes
David Senitzer, City of Hope Comprehensive Cancer Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: David Senitzer, PhD Beckman Research Institute
City of Hope Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP