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

Not Applicable

Terminated

• Conditions: Graft Versus Host Disease (GVHD)
• Interventions: Procedure: extracorporeal photopheresis; Other: laboratory biomarker analysis

• Registration Number: NCT01324908
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Study Timeline

• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-26
• Study First Posted: 2011-03-29
• Study Start: 2011-07
• Primary Completion: 2017-07-28
• Study Completion: 2020-11-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (Treg predictor of response to ECP)	extracorporeal photopheresis	Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.
Treatment (Treg predictor of response to ECP)	laboratory biomarker analysis	Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Dana Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Virginia Commonwealth University, Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States