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Investigation of the Cylex® ImmuKnow® Assay

Sponsor
Indiana University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00569842
Collaborator
(none)
45
Enrollment
1
Location
61
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Investigation of the Cylex® ImmuKnow® Assay
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Feb 1, 2010
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    observational

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

      1. Acute leukemia

      2. Non-Hodgkin's Lymphoma

      3. Chronic lymphocytic leukemia

      4. Hodgkin's disease

      5. Multiple myeloma

      6. Myelodysplastic Syndromes

      7. Myeloproliferative Disorders

      8. Aplastic Anemia

      9. Chronic myelogenous leukemia

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Indiana Universtiy Simon Cancer Center Indianapolis Indiana United States 46202

      Sponsors and Collaborators

      • Indiana University School of Medicine

      Investigators

      • Principal Investigator: Sherif Farag, MD, PhD, Indiana University School of Medicine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Indiana University School of Medicine
      ClinicalTrials.gov Identifier:
      NCT00569842
      Other Study ID Numbers:
      • 0710-11/ IUCRO-0207
      First Posted:
      Dec 7, 2007
      Last Update Posted:
      Sep 11, 2014
      Last Verified:
      Sep 1, 2014
      Additional relevant MeSH terms:
      Leukemia
      Multiple Myeloma
      Leukemia, Lymphocytic, Chronic, B-Cell
      Leukemia, Myeloid
      Leukemia, Myelogenous, Chronic, BCR-ABL Positive
      Hodgkin Disease
      Myelodysplastic Syndromes
      Anemia, Aplastic
      Myeloproliferative Disorders

      Study Results

      No Results Posted as of Sep 11, 2014