Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD

Phase 3

• Conditions: Steroid Refractory GVHD

• Registration Number: NCT04289103
• Lead Sponsor: ElsaLys Biotech

Brief Summary

A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17
• Study Start: 2021-10
• Primary Completion: 2022-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
• Age 28 days to < 18 years old
• Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
• Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
• Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)

Exclusion Criteria

• Isolated stage 1 skin SR-aGvHD
• Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
• Acute GvHD after donor lymphocytes infusion (DLI)
• Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
• Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
• Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
• Known allergy or intolerance to Leukotac of one of its ingredients
• Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
• Other ongoing interventional protocol that might interfere with

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response	Day 29 post inclusion	Complete response + very good partial response + partial response