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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis

Conditions
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Graft Versus Host Disease (GVHD)

Intervention / Treatment
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* Procedure: extracorporeal photopheresis
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Treg predictor of response to ECP)<br>Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks. | Procedure: extracorporeal photopheresis<br>* Undergo ECP<br>* Other names: extracorporeal photophoresis;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP. |  | 6 months after last patient is on study | 

Secondary Outcome Measures

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