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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174277
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : January 10, 2017
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
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 or disease Intervention/treatment
Blood Stem Cell Transplant Failure Graft Versus Host Disease Other: Collection of blood sample

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunological Changes in Chronic Graft Versus Host Disease Treated With Extracorporeal Photopheresis
Study Start Date : August 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Determine effects of ECP using Cellex on T and B cell subsets and CD4+ cell differentiation [ Time Frame: 2 years ]
    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 :
  1. To correlate the effects of ECP on immunologic parameters with clinical outcomes. [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174277

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Kansas Medical Center
Principal Investigator: Sunil Abhyankar, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center Identifier: NCT01174277     History of Changes
Other Study ID Numbers: 12179
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

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

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