Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD

Launched by MOLLY GALLOGLY · Apr 11, 2022

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ClinConnect Summary

This is a Phase II study of human MSCs for the treatment of High-Risk aGVHD (HRaGVHD) and steroid-refractory acute GVHD (SRaGVHD). MSCs are cells that can help the body heal from injury and maintain a healthy immune system. MSCs have been used to prevent and treat a GvHD. In previous human studies, MSC infusion has been generally well-tolerated and safe, and in some cases, benefit was reported. The donor of the MSCs could be a relative or a stranger, and does not need to be the same individual who donated the stem cells for the stem cell transplant. All donors are screened for infectious di...

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Eligibility criteria

• 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