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Investigation of the Cylex® ImmuKnow® Assay

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00569842
First received: December 5, 2007
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Leukemia
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic Myelogenous Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of the Cylex® ImmuKnow® Assay

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Biospecimen Retention:   None Retained

None to be retained.


Enrollment: 45
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
observational

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569842

Locations
United States, Indiana
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 Simon Cancer Center
  More Information

Additional Information:
Indiana University Simon Cancer Center: Find a Clinical Trial  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00569842     History of Changes
Other Study ID Numbers: 0710-11/ IUCRO-0207
Study First Received: December 5, 2007
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
 Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 16, 2013