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Clinical Trial VICCBMT1063

Title

T-Regulatory Homing Subsets as a Predictor of Response in GVHD Treated with Extracorporeal Photopheresis

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCBMT1063
  • Open Date: 07/27/2011
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: To show that ECP increases skin and gut homing T regulatory cells in patients with GVHD clinically responded to ECP
  • Disease Sites: Hematologic
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Virginia Commonwealth University - Massey Cancer CenterEmory UniversityDana-Farber Cancer InstituteVanderbilt University
  • National Clinical Trial ID: NCT01324908
  • Secondary Protocol No: Not Specified

Description

Graft-versus-host disease (GVHD) is a common complication occurring after allogeneic stem cell transplant (SCT). This condition has been historically classified as acute (onset within first 100 days of allogeneic SCT) and chronic (onset after 100 days of allogeneic SCT). Chronic GVHD has can resemble a variety of autoimmune disorders, and has been previously classified as limited and extensive, although the prognostic significance of this classification is unclear. Many agents have been studied to alleviate steroid dependent/refractory GVHD. Extracorporeal photopheresis (ECP) is effective in the treatment of GVHD and has been used with variable efficacy. ECP involves exposure of peripheral blood mononuclear cells to a photoactivated substance called -8-MOP-, followed by reinfusion of the treated cells back into the patient. Target organ responsiveness varies widely and depends on type of GVHD (acute or chronic), and previous treatment (steroid-refractory or dependent). A recent randomized study showed that ECP decreases the steroid usage in some patients with GVHD. Biological factors predicting organ involvement and severity of GVHD remain unknown. Regulatory T cells (Tregs) are a suppressive subset of immune cells that may help prevent aGVHD. Tregs can potentially play a part in conferring organ-specific immune regulation. Emerging data suggests that ECP may effect responsiveness via a T-reg mediated process. The impact of ECP on homing subsets of T-regs remains unknown. This study aims to: -show that ECP increases skin and gut homing T regulatory cells in patients with GVHD clinically responding to ECP We will also: -prospectively study the response rates of GVHD with ECP using NIH consensus criteria for diagnoses, severity and response and -prospectively study the association of T-reg (both total and homing subset) with the various NIH subtypes

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