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

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.
 
ClinicalTrials.gov Identifier: NCT01324908
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date  ICMJE March 7, 2011
First Posted Date  ICMJE March 29, 2011
Last Update Posted Date September 10, 2019
Study Start Date  ICMJE July 2011
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
Official Title  ICMJE T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Graft Versus Host Disease (GVHD)
Intervention  ICMJE
  • Procedure: extracorporeal photopheresis
    Undergo ECP
    Other Name: extracorporeal photophoresis
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 11, 2017)
85
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2011)
203
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01324908
Other Study ID Numbers  ICMJE VICC BMT 1063
NCI-2011-00225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor  ICMJE Vanderbilt-Ingram Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Madan Jagasia Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date September 2019

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