Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
This study is currently recruiting participants.
Verified May 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01324908
First received: March 7, 2011
Last updated: May 11, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Graft Versus Host Disease (GVHD) |
Procedure: extracorporeal photopheresis Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rates of GVHD with ECP as measured by NIH response criteria [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 203 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324908
Contacts
| Contact: VICC Clinical Trials Information Program | 800-811-8480 |
Locations
| United States, Georgia | |
| Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Cynthia Giver, PhD 404-778-5806 | |
| Principal Investigator: Cynthia Giver, PhD | |
| United States, Massachusetts | |
| Dana Farber Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Yi-Bin Chen, MD 617-724-1124 ext 2 | |
| Principal Investigator: Yi-Bin Chen, MD | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: VICC Clinical Trials Program 800-811-8480 | |
| Principal Investigator: Madan H. Jagasia | |
| United States, Virginia | |
| Virginia Commonwealth University, Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: William Clark, MD 804-828-1292 | |
| Principal Investigator: William Clark, MD | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Madan Jagasia | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01324908 History of Changes |
| Other Study ID Numbers: | VICC BMT 1063, NCI-2011-00225 |
| Study First Received: | March 7, 2011 |
| Last Updated: | May 11, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013