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



Status:Active, not recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:July 2011
End Date:December 2019

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

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.

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.

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
We found this trial at
4
sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Madan H. Jagasia
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Cynthia Giver, PhD
Phone: 404-778-5806
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: William Clark, MD
Phone: 804-828-1292
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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Richmond, VA
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Boston, Massachusetts 02115
Principal Investigator: Yi-Bin Chen, MD
Phone: 617-724-1124
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Boston, MA
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