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

NCT ID: NCT04289103

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-06-30

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)

Conditions

Steroid Refractory GVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Inolimomab (Leukotac)

Intervention Type: BIOLOGICAL

• 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElsaLys Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

INO-108

Identifier Type: -

Identifier Source: org_study_id