Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT
A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem Cell Transplant Treated With DSC or BAT
Mats Remberger
50 participants
Dec 1, 2021
INTERVENTIONAL
Summary
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.
Eligibility
Inclusion Criteria2
- Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.
- Signed written study informed consent once SR-aGvHD is confirmed.
Exclusion Criteria16
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
- Has received systemic treatment for aGvHD apart from steroids.
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome.
- Pregnant or lactating women.
- Significant respiratory disease.
- Presence of severely impaired renal function
- Any corticosteroid therapy for indications other than aGvHD
- Previous participation in a study of any investigational treatment agent within 30 days
- Known human immunodeficiency virus infection (HIV).
- Patients suffering on active tuberculosis or viral hepatitis
- Significant respiratory disease
- Presence of severely impaired renal or liver function
- History of progressive multifocal leuko-encephalopathy
- Patients with coagulopathy
- History of severe chronic history of heart disease
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
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Interventions
Placenta-derived Decidua Stroma Cells. The product consists of a viable allogeneic DSCs frozen in 5% of human serum albumin (HSA) in sodium chloride (NaCl) 0.9% and 10% dimethylsulfoxide (DMSO), that is thawed and immediately diluted in 40 mL sodium chloride (NaCl) 0.9% prior to infusion. That will give a final concentration of 2.2% HSA and 2% DMSO. DSC will be infused when steroid-refractory acute GVHD after allogenic stem-cell transplantation has been diagnosed. Two doses, one week apart, will be given to all patients. Additional doses will be used depending on response.
The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT04118556