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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2008

Last Updated Date

March 3, 2011

Start Date ^ICMJE

June 2008

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00813501 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation

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.

Detailed Description

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

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

Intervention ^ICMJE

Biological: immunosuppressive therapy
Other: immunological diagnostic method
Procedure: allogeneic hematopoietic stem cell transplantation

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00813501

Other Study ID Numbers ^ICMJE

07200, P30CA033572, CHNMC-07200, CDR0000628793

Has Data Monitoring Committee

Yes

Responsible Party

David Senitzer, City of Hope Comprehensive Cancer Center

Study Sponsor ^ICMJE

City of Hope Medical Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

David Senitzer, PhD

Beckman Research Institute

Information Provided By

City of Hope Medical Center

Verification Date

March 2011

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

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