A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)


About this study

The purpose of this study is to compare the effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Is willing and able to provide written informed consent/assent and to comply with all
protocol procedures and assessments required for the study.

2. Is age ≥ 12 years and > 40kg at informed consent/assent.

3. Has had an initial allogeneic HSCT for any indication using any graft source, donor
source, conditioning regimen intensity or prophylaxis.

4. Has evidence of myeloid engraftment

5. 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.

6. 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

Exclusion Criteria:

1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy,
with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the

2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after

3. Evidence of persistent molecular disease requiring treatment that was not specified
prior to HSCT.

4. Evidence of cGVHD or overlap syndrome

5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.

6. 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.

Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hogan, M.B., B.Ch.

Open for enrollment

Contact information:

Jordan Scheevel

(507) 422-4126


More information


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