A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
12 Years and older, Male and Female
EQ-100-02 (primary)
NCI-2022-02430
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
Objectives
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.
Eligibility
- 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 â?¥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 â?¤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
Treatment Sites in Georgia
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