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

Primary Purpose

Graft Versus Host Disease (GVHD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
extracorporeal photopheresis
laboratory biomarker analysis
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease (GVHD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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

Sites / Locations

  • Emory University
  • Dana Farber Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • Virginia Commonwealth University, Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (Treg predictor of response to ECP)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rates of GVHD with ECP as measured by NIH response criteria
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD

Full Information

First Posted
March 7, 2011
Last Updated
January 11, 2021
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01324908
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
November 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease (GVHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (Treg predictor of response to ECP)
Arm Type
Experimental
Arm Description
Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
extracorporeal photopheresis
Other Intervention Name(s)
extracorporeal photophoresis
Intervention Description
Undergo ECP
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
Time Frame
6 months after last patient is on study
Secondary Outcome Measure Information:
Title
Response rates of GVHD with ECP as measured by NIH response criteria
Time Frame
at 6 months
Title
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD
Time Frame
at 6 months
Title
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madan Jagasia
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dana Farber Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Virginia Commonwealth University, Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

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

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