Pilot Study: Patients With Chronic Active Graft Versus Host Disease That Have Failed or Not Tolerated Standard Therapy.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01174277
First received: July 27, 2010
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

By doing this study, researchers hope to understand the many changes that occur in the blood of people who have chronic GvHD. This may also help the researcher understand how ECP works and help guide therapy for patients who have chronic GvHD in the future.


Condition Intervention Phase
Blood Stem Cell Transplant Failure
Graft Versus Host Disease
Other: Collection of blood sample
Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunological Changes in Chronic Graft Versus Host Disease Treated With Extracorporeal Photopheresis

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Determine effects of ECP using Cellex on T and B cell subsets and CD4+ cell differentiation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Flow cytometry will be used to characterize T and B cell subsets in the blood of ECP patients. We will also isolate CD4+ T cells from ECP patients, stimulate the cells in culture, and measure proliferation and cytokine production. These assays will be performed prior to ECP therapy and at two, four and six months following ECP therapy.


Secondary Outcome Measures:
  • To correlate the effects of ECP on immunologic parameters with clinical outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will measure serum levels of eight biomarkers known to correlate with GvHD and evaluate the patients for clinical signs of GvHD. The biomarkers and clinical signs will be correlated with the immunologic parameters described in the primary outcome measure.


Biospecimen Retention:   Samples With DNA

Blood samples will be collected at study entry and at 2, 4, 6 and 12 months following treatment


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Collection of blood sample
Blood draw
Other: Collection of blood sample
Participation involves collection of blood sample at baseline, 2, 4, 6 and 12 months regardless of whether or not patients continue on treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have undergone allogeneic HSCT and are being managed for chronic Graft versus Host Disease by the University of Kansas Blood and Marrow Transplantation Program, and the Children's Mercy Hospital BMT program, will be invited to take part in the study.

Criteria

Inclusion Criteria:

  • Allogeneic HSCT recipients who have chronic extensive GvHD and who have failed or have not been able to tolerate conventional therapy
  • Platelets ≥ 20,000 without transfusion support
  • Weight ≥ 15 kg.
  • Stated willingness to use contraception in women of childbearing potential

Exclusion Criteria:

  • Patients who may not be able to tolerate ECP
  • Patients who have received Rituximab monoclonal antibody therapy in the past 3 months
  • Patients with a known hypersensitivity to psoralens
  • Pregnant or breastfeeding
  • Patients who are unable to sign informed consent or who do not have a representative to give permission to participate
  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: NCT01174277

Contacts
Contact: Sunil Abhyankar, MD 913-588-6030 sabhyankar@kumc.edu
Contact: Jennifer Bunch 913-945-7713 jbunch@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jennifer Bunch    913-945-7713    jbunch@kumc.edu   
Sub-Investigator: Thomas Yankee, MD         
United States, Missouri
Children's Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Sunil Abhyankar, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01174277     History of Changes
Other Study ID Numbers: 12179
Study First Received: July 27, 2010
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
chronic graft versus host disease
transplant
stem cell

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on October 21, 2014