Acute Graft Versus Host Disease MedDRA version: 22.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10018799 Term: GVHD System Organ Class: 100000004870
Conditions
Sponsors
Equillium, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =12 years and >40 kg at informed consent/assent. Subjects =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Has evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast. - Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT. - Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT. -Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria. - Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted. - Has received 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. Systemic corticosteroids administered as premedication before blood product transfusions or IV medications to prevent infusion-related reactions are allowed. - Has a clinically active, uncontrolled bacterial, viral, or fungal infection, despite adequate treatment. No signs of progression of the infection can be present at randomization. Asymptomatic cytomegalovirus (CMV), Epstein–Barr virus (EBV), or human Herpesvirus 6 (HHV-6) viremia based on viral load or a viral load that is declining with treatment does not constitute a clinically active infection. Other protocol-defined exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.;Secondary Objective: • 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;Primary end point(s): Primary endpoint Complete Response rate at Day 29.;Timepoint(s) of evaluation of this end point: Primary endpoint Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: 1) Overall response rate at day 29 2) Durable complete response rate from Day 29 through Day 99;Timepoint(s) of evaluation of this end point: 1) Day 29 2) Day 29 through Day 99 | — |
Countries
France, Spain
Contacts
Public ContactClinical Trials Information
Equillium, Inc.
Outcome results
None listed