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
Primary Objective
To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
Secondary Objectives
To evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
To evaluate systemic corticosteroid use in subjects treated with itolizumab versus placebo.
To assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, including survival outcomes and cGVHD incidence.
To evaluate the safety and tolerability of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
Exploratory Objectives
To evaluate the impact of itolizumab versus placebo on health-related quality of life in subjects with aGVHD.
To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) properties of itolizumab in subjects with aGVHD.
To assess changes in biomarker expression following treatment with itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Amer Assal MD
- Principal Investigator
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
1.
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
breast.
2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after
HSCT.
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.