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

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:	Intervention Model: Single Group Assignment Masking: None (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:

Genetic and Rare Diseases Information Center resources: Homologous Wasting Disease

U.S. FDA Resources

Further study details as provided by Madan Jagasia, MD, 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 ]

Secondary Outcome Measures:

Response rates of GVHD with ECP as measured by NIH response criteria [ Time Frame: at 6 months ]
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ]
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ]


Enrollment:	85
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	October 2018 (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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Locations


United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana Farber Cancer Center
Boston, Massachusetts, United States, 02114
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Virginia
Virginia Commonwealth University, Massey Cancer Center
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Madan Jagasia	Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial This link exits the ClinicalTrials.gov site


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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received:	March 7, 2011
Last Updated:	August 11, 2017

Additional relevant MeSH terms:


Graft vs Host Disease Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2017