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

Protocol # :
Graft Versus Host Disease
Acute-graft-versus-host Disease
Acute GVHD
Disease Sites
Transplanted organ and tissue status, unspecified
Other Hematopoietic
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Leukemia, other
Principal Investigator
Koreth, John
Site Research Nurses
Aiken, Haley
Beshere, Gianna
Brock, Jennifer
Halloran, Elizabeth
Maciejewski, Ashley, Taylor
More, Avnee, P.
Smith, Caitlin
Tichon, Jennifer

Trial Description

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

Eligibility Requirements

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.