RATinG: Risk Adapted Therapy in Acute GvHD; investigating the use of Lenzilumab for treating high-risk acute graft versus host disease following allogenic stem cell transplantation.
Study design/summary: A multicentre, phase II/III, randomised (1:1) clinical trial of Lenzulimab compared to placebo in patients with acute GvHD following allogenic stem cell transplantation. Potentially eligible patients will be screened for expression of ST2 and REG3α using a validated assay and assigned a risk score. High-risk patients (interventional cohort) will be eligible for study entry and randomisation between Lenzulimab and placebo (1:1); low-risk patients will form an observational cohort and be treated as per standard of care.
- Primary objective will be to study non-relapse mortality (NRM) at 6 months post-transplant.
- Secondary objectives will be to determine biomarker risk score at D28 of treatment; response (complete remission + partial remission) at D28 of treatment; cumulative corticosteroid exposure at 6 months; time to treatment failure (increased dose of corticosteroids or starting additional systemic GvHD treatment); cumulative incidence and severity of chronic GvHD (cGvHD); overall survival (OS) at 1 year; GvHD- and relapse free survival at 1 year (GRFS); toxicity including adverse events of special interest; patient-reported outcomes; Lenzulimab immunogenicity, PK and PD. Samples will also be collected for translational research projects in a subset of patients.
Centres: 22 IMPACT centres & additional non-IMPACT centres
Target Number of patients: 220 patients will be randomised to receive either Lenzulimab or placebo (1:1); up to 370 patients will be recruited to the observational cohort.
Patient population: Adults with acute GvHD following allogenic stem cell transplantation will be recruited to this trial.
Sponsorship/Funding: RATinG is sponsored by the University of Birmingham. The trial will be delivered by IMPACT-funded Research Nurses at 9 IMPACT centres. The facilitatory hub, located at the CRCTU at the University of Birmingham, is funded by IMPACT.
Trial Status: Open to recruitment
Trial contacts: RATING@trials.bham.ac.uk
Duration: Patients will be recruited over 3 years and will be followed up for 6 months. Long-term follow up will capture data regarding GvHD treatments as a surrogate for GvHD progression, relapse of underlying disease and survival.
If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you. A referral from your medical team would be required in order to consider you for treatment on a clinical trial.