Clinical trial NCT01324908: Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
Official title: T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Graft Versus Host Disease (GVHD)
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-03-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
timeFrame: 6 months after last patient is on study
Secondary outcomes:
measure: Response rates of GVHD with ECP as measured by NIH response criteria
timeFrame: at 6 months
measure: Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD
timeFrame: at 6 months
measure: Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD
timeFrame: at 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Center
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University, Massey Cancer Center
state: Virginia
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Madan Jagasia
role: PRINCIPAL_INVESTIGATOR
References: