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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

Description

Brief Summary
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids


Detailed Description
This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.

Phase

N/A

Inclusion and Exclusion Criteria

  • Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
  • Is age ≥12 years and >40kg at informed consent/assent.
  • Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
  • Has evidence of myeloid engraftment
  • Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
  • Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.

  • Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
  • An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
  • Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
  • Evidence of cGVHD or overlap syndrome
  • Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
  • Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por SC CTSI