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A Phase 3 Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease (Complication of Bone Marrow Transplants).
EU CTIS ID: 2024-516064-28-00
What this study is testing
To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥12 years and >40 kg at informed consent/assent. Subjects <18 years may only enroll if locally permitted.
- 2. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. NOTE: 2 allogeneic HSCTs may be allowed if GVHD did not occur after the first HSCT.
- 3. Has evidence of myeloid engraftment, defined as an absolute neutrophil count ≥500/mm3 (or ≥0.5 × 10exp9/L) achieved and sustained for 3 laboratory values obtained on different days. Laboratory values prior to Screening may be used.
- 4. 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 - at Screening and randomization. Biopsies to confirm aGVHD should be obtained but are not required and should not delay entry into the study.
- 5. Began initial systemic corticosteroid treatment with ≥ 1mg/kg/day methylprednisolone or equivalent 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.
You likely can't join if
- 1. 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.
- 2. Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
- 3. Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT.
- 4. Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria.
- 5. Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted.
- 6. 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.
See the full eligibility criteria
Who can join
- 1. Age ≥12 years and >40 kg at informed consent/assent. Subjects <18 years may only enroll if locally permitted.
- 2. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. NOTE: 2 allogeneic HSCTs may be allowed if GVHD did not occur after the first HSCT.
- 3. Has evidence of myeloid engraftment, defined as an absolute neutrophil count ≥500/mm3 (or ≥0.5 × 10exp9/L) achieved and sustained for 3 laboratory values obtained on different days. Laboratory values prior to Screening may be used.
- 4. 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 - at Screening and randomization. Biopsies to confirm aGVHD should be obtained but are not required and should not delay entry into the study.
- 5. Began initial systemic corticosteroid treatment with ≥ 1mg/kg/day methylprednisolone or equivalent 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.
What rules you out
- 1. 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.
- 2. Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
- 3. Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT.
- 4. Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria.
- 5. Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted.
- 6. 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.
- 7. 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.
- 8. Other Protocol-defined criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- New Zealand
- Korea, Republic of
- Canada
- United Kingdom
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; New Zealand; Korea, Republic of; Canada; United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.