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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01324908
First Posted: March 29, 2011
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
March 7, 2011
March 29, 2011
August 15, 2017
July 2011
October 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01324908 on ClinicalTrials.gov Archive Site
  • Response rates of GVHD with ECP as measured by NIH response criteria [ Time Frame: at 6 months ]
  • Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ]
  • Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ]
Same as current
Not Provided
Not Provided
 
Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Graft Versus Host Disease (GVHD)
  • Procedure: extracorporeal photopheresis
    Undergo ECP
    Other Name: extracorporeal photophoresis
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: 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.
Interventions:
  • Procedure: extracorporeal photopheresis
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
December 2018
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01324908
VICC BMT 1063
NCI-2011-00225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Not Provided
Not Provided
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Madan Jagasia Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP