Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03851601
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Shatha Farhan, Henry Ford Health System

Brief Summary:
Extracorporeal Photopheresis (ECP) has been used as one of the treatments for graft versus host disease (GVHD). Responses were observed in skin, liver, GI tract, mouth, eye and lung. ECP does not cause immune suppression and therefore less risk of infection or relapse of malignancy. However, the exact mechanism of action of this expensive procedure is not fully understood and no predictors of response to ECP are known so far. This reflects the need for a better understanding of GVHD and its response to ECP. Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using flow cytometer

Condition or disease Intervention/treatment
GVHD Other: blood samples

Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immuno-regulatory Profiling of T Cells in Patients With Graft Versus Host Disease Treated With Extracorporeal Photopheresis
Actual Study Start Date : August 26, 2014
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ECP
Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer
Other: blood samples
Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer




Primary Outcome Measures :
  1. effect of ECP on Tregs/TH17 ratio [ Time Frame: 6 months ]
    investigate the effect of ECP on Tregs/TH17 ratio using flow-cytometry in patients with GVHD who receive treatment with ECP


Biospecimen Retention:   Samples Without DNA
Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are recipients of allogeneic stem cell grafts.
  2. Patients with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP
  3. Patient must have 100% chimerism with the donor
  4. No recent donor lymphocyte infusion.
  5. Patients must be able to sustain a platelet count and a hematocrit > 20,000/mL and > 27% respectively, with or without transfusions.
  6. The absolute WBC must be >1500/mL
  7. Patient must be willing to comply with all study procedures.

Exclusion criteria:

  1. Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.
  2. Active bleeding.
  3. International normalized ration (INR) >2.
  4. Patients with known hypersensitivity or allergy to psoralen.
  5. Patients with known hypersensitivity or allergy to both citrate and heparin.
  6. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
  7. Active, uncontrolled infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851601


Locations
Layout table for location information
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: shatha farhan, MD    313-713-3910    SFARHAN1@HFHS.ORG   
Contact: Nalini Janakiraman    313 916 5002      
Sponsors and Collaborators
Henry Ford Health System

Layout table for additonal information
Responsible Party: Shatha Farhan, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03851601     History of Changes
Other Study ID Numbers: 9101
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No