Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD

This is an interventional treatment trial for Graft Versus Host Disease Read More

Inclusion Criteria:

-One of the following diagnoses:

--High risk aGVHD, either biopsy proven or clinical diagnosed as defined by either:

• Skin stage 4
• Lower gastrointestinal (GI) stage ≥ 3
• Liver stage ≥ 3
• Skin stage 3 and lower GI or liver stage ≥ 2 GVHD
• Hyper-acute GVHD as defined by aGVHD within the first 14 days of transplant
• Overall grade 2-4 aGVHD with high-risk disease identified by the Viracor Eurofins Symptomatic Onset or Post-Treatment Algorithm

OR:

--Steroid refractory aGVHD (either biopsy proven or clinical diagnosed) as defined by any one of the following criteria per NCCN (National Comprehensive Cancer Network) Guidelines for Hematopoietic Cell Transplantation (HCT):

• Progression of aGVHD within 3-5 days of therapy onset with ≥ 2 mg/kg/day of methylprednisolone or equivalent
• Failure to improve within 5-7 days of treatment initiation (2 mg/kg/day of methylprednisolone or equivalent)

• Incomplete response after more than 28 days of immunosuppressive treatment including steroids (2 mg/kg/day of methylprednisolone or equivalent)

  • Hct > 27 and plts > 50,000 x10^9/L (may be achieved via transfusion on ECP days)
  • Candidate for appropriate vascular access for ECP, which may include: (1) peripheral IV with 16 or 17 gauge Fistula needle; (2) central venous access device (apheresis catheter, tunneled central vascular access device), (3) vortex implanted port; (4) Bard POWERFLOW® implanted port
  • Eastern Cooperative Oncology Group Performance status ≤ 3
  • Participants who underwent an allogeneic hematopoietic stem cell transplantation from any donor source
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Active malignancy
• Contraindication to photopheresis, including any of the following: (1) known sensitivity to psoralen compounds such as 8-MOP; (2) comorbidities that may result in photosensitivity; (3) aphakia; (4) insufficient weight/circulating volume (defined by photopheresis machine characteristics); (5) hemodynamic instability; (6) platelet count < 20 x 109/μL despite platelet support; (7) bleeding diathesis; (8) hematocrit < 27 despite red blood cell support; (9) inability to lie flat for 4 hours; (10) inadequate venous access
• Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC (Reduced-Intensity Conditioning) have the significant potential for teratogenic or abortifacient effects.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
• Progressive underlying malignant disease or post-transplant lymphoproliferative disease