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Low Dose Ruxolitinib in Combination With Methylprednisolone 1mg/kg as Initial Therapy for Acute Graft-Versus-Host Disease

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Trial Profile

Low Dose Ruxolitinib in Combination With Methylprednisolone 1mg/kg as Initial Therapy for Acute Graft-Versus-Host Disease

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Dec 2021

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At a glance

  • Drugs Methylprednisolone (Primary) ; Prednisone (Primary) ; Ruxolitinib (Primary) ; Ciclosporin
  • Indications Graft-versus-host disease
  • Focus Therapeutic Use

Most Recent Events

  • 12 Dec 2021 Status changed from recruiting to completed.
  • 14 Jul 2020 Study design changed from Single Group Assignment to Sequential Assignment. Allocation changed to Non-Randomized. Study Phase changed from Phase 2 to Phase 1/Phase 2. Number of arms changed from 1 to 4. Experimental arm: Ruxolitinib 10 mg twice a day, Ruxolitinib 5 mg twice a day and Ruxolitinib 2.5 mg twice a day in combinations with Corticosteroids added to study protocol. Planned number of subjects also increased.
  • 14 Jul 2020 Planned number of patients changed from 30 to 32.

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