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

NCT01174277 | Completed DMC

• 1 other identifier: 12179
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Blood Stem Cell Transplant Failure; Graft Versus Host Disease

Keywords

chronic graft versus host disease; transplant; stem cell

Outcome Measures

Primary Outcomes (1)

• Determine effects of ECP using Cellex on T and B cell subsets and CD4+ cell differentiation

  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.

  2 years

Secondary Outcomes (1)

• To correlate the effects of ECP on immunologic parameters with clinical outcomes.

  2 years

Study Arms (1)

Collection of blood sample

Blood draw

Other: Collection of blood sample

Interventions

Collection of blood sample OTHER

Participation involves collection of blood sample at baseline, 2, 4, 6 and 12 months regardless of whether or not patients continue on treatment.

Collection of blood sample

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Sunil Abhyankar, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: August 3, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (2)