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
  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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813501

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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 July 20, 2014