Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01324908
First received: March 7, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.


Condition Intervention
Graft Versus Host Disease (GVHD)
Procedure: extracorporeal photopheresis
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP. [ Time Frame: 6 months after last patient is on study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates of GVHD with ECP as measured by NIH response criteria [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 203
Study Start Date: July 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Treg predictor of response to ECP)
Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.
Procedure: extracorporeal photopheresis
Undergo ECP
Other Name: extracorporeal photophoresis
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVE:

I. To show that extracorporeal photopheresis (ECP)increases skin and gut homing T regulatory (T-reg) cells in patients with GVHD clinically responding to ECP.

SECONDARY OBJECTIVES:

I. Response rates of GVHD with extracorporeal photopheresis(ECP)as measured by NIH response criteria

II. Incidence of T-reg cell frequency(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)

III. Incidence of T-reg homing subsets(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)

OUTLINE:

Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.

After completion of study treatment, patients are followed up at 2, 4, and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with any NIH subtype of chronic GVHD that is being treated with ECP
  • Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
  • Life expectancy > 3 months
  • Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
  • If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
  • No use of an investigational agent within 2 weeks of starting ECP
  • No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
  • No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
  • Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Exclusion Criteria:

  • Female patients who are breastfeeding or pregnant
  • Patients known to be human immunodeficiency virus (HIV) positive
  • Bronchiolitis obliterans as the sole indication of ECP
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
  • Stage 4 gastrointestinal GVHD as per Seattle-Glucksberg criteria
  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: NCT01324908

Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Cynthia Giver, PhD    404-778-5806      
Principal Investigator: Cynthia Giver, PhD         
United States, Massachusetts
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yi-Bin Chen, MD    617-724-1124 ext 2      
Principal Investigator: Yi-Bin Chen, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: VICC Clinical Trials Program    800-811-8480      
Principal Investigator: Madan H. Jagasia         
United States, Virginia
Virginia Commonwealth University, Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: William Clark, MD    804-828-1292      
Principal Investigator: William Clark, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Madan Jagasia Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01324908     History of Changes
Other Study ID Numbers: VICC BMT 1063, NCI-2011-00225
Study First Received: March 7, 2011
Last Updated: April 16, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014