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

ElsaLys Biotech

Status and phase: Not yet enrolling; Phase 3

Conditions: Steroid Refractory GVHD

Treatments: Biological: Inolimomab (Leukotac)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289103

INO-108

Details and patient eligibility

About

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)

Enrollment: 65 estimated patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Inolimomab/Leukotac

Experimental group

Description:

* Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study. * Treatment phase - Leukotac will be given up to D28 * Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion

Treatment:

Biological: Inolimomab (Leukotac)