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

NCT ID: NCT01324908

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2020-11-16

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.

Conditions

Graft Versus Host Disease (GVHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (Treg predictor of response to ECP)

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

Group Type: EXPERIMENTAL

extracorporeal photopheresis

Intervention Type: PROCEDURE

Undergo ECP

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

extracorporeal photopheresis

Undergo ECP

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

extracorporeal photophoresis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Byrne

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madan Jagasia

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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

Countries

United States

Related Links

http://www.vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

NCI-2011-00225

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC CTT 1063

Identifier Type: -

Identifier Source: org_study_id