NCT01324908

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

6.1 years

First QC Date

March 7, 2011

Last Update Submit

January 11, 2021

Conditions

Graft Versus Host Disease (GVHD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Treatment (Treg predictor of response to ECP)

EXPERIMENTAL

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

Procedure: extracorporeal photopheresisOther: laboratory biomarker analysis

Interventions

extracorporeal photopheresisPROCEDURE

Undergo ECP

Also known as: extracorporeal photophoresis
Treatment (Treg predictor of response to ECP)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (Treg predictor of response to ECP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02114, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Virginia Commonwealth University, Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Related Links

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Madan Jagasia

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 29, 2011

Study Start

July 1, 2011

Primary Completion

July 28, 2017

Study Completion

November 16, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

US(4)