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

Steroid Refractory GVHD Clinical Trial

— EiFFEL  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04289103
• Other study ID #: INO-108
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2020
• Source: ElsaLys Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: June 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Steroid Refractory GVHD

Intervention

Biological:
• Inolimomab (Leukotac)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ElsaLys Biotech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response	Complete response + very good partial response + partial response	Day 29 post inclusion