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A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
About
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
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion 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.
Exclusion Criteria:
- 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.
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Study Stats
Protocol No.
22-000328
Category
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood