Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
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ClinicalTrials.gov Identifier: NCT01324908 |
Recruitment Status :
Terminated
(Low accrual)
First Posted : March 29, 2011
Last Update Posted : January 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Versus Host Disease (GVHD) | Procedure: extracorporeal photopheresis Other: laboratory biomarker analysis | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 28, 2017 |
Actual Study Completion Date : | November 16, 2020 |

Arm | Intervention/treatment |
---|---|
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.
|
Procedure: extracorporeal photopheresis
Undergo ECP
Other Name: extracorporeal photophoresis Other: laboratory biomarker analysis Correlative studies |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01324908
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Dana Farber Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 | |
United States, Virginia | |
Virginia Commonwealth University, Massey Cancer Center | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Madan Jagasia | Vanderbilt-Ingram Cancer Center |
Responsible Party: | Michael Byrne, Principal Investigator, Vanderbilt-Ingram Cancer Center |
ClinicalTrials.gov Identifier: | NCT01324908 |
Other Study ID Numbers: |
VICC CTT 1063 NCI-2011-00225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | March 29, 2011 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Graft vs Host Disease Immune System Diseases |