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 =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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.