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A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.
Primary Objective: To assess the rate of complete response (CR) in Grades III and IV SR-aGVHD participants on Day 28 post-randomization. Secondary Objectives: 1. Estimate the overall survival (OS) at Days 60, 90, and 180. 2. Evaluate the duration of complete response (DoCR). 3. Estimate the time to complete response (CR) from randomization. 4. Estimate the overall response rate (CR or partial response (PR)) at Days 14, 28, and 56. 5. Describe proportions of CR, PR, mixed response (MR), no response (NR), and progression of aGVHD at Days 6, 14, 28, and 56. 6. Estimate the cumulative incidence of non-relapse mortality (NRM) at Days 90 and 180. 7. Estimate relapse-free survival at Day 180. 8. Estimate GVHD-free survival at Days 90 and 180. 9. Estimate the cumulative incidence of chronic GVHD (cGVHD) at Day 180. 10. Estimate the cumulative incidence of underlying disease relapse/progression at Day 180. 11. Describe the incidence of infections. 12. Describe the incidence of toxicities. 13. Assess the pharmacokinetics (PK) of T-Guard. 14. Assess the immunogenicity of T-Guard.
Chemotherapy (NOS); Therapy (NOS)
Clemastine (); Diphenhydramine (); Jakafi (Ruxolitinib); Ruxolitinib (); T-Guard (); acetaminophen ()
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