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

18 Years
Open (Enrolling)
Graft Versus Host Disease (GVHD)

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Trial Information

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


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.


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

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)


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

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

- 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not part of normal medical care, with the understanding that consent may be withdrawn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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.

Outcome Time Frame:

6 months after last patient is on study

Safety Issue:


Principal Investigator

Madan Jagasia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2011

Completion Date:

September 2017

Related Keywords:

  • Graft Versus Host Disease (GVHD)
  • Graft vs Host Disease



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Emory University Atlanta, Georgia  30322
Dana Farber Cancer Center Boston, Massachusetts  02115
Virginia Commonwealth University, Massey Cancer Center Richmond, Virginia  23298