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

NCT04289103 | Unknown Phase 3 FDA Drug

• 1 other identifier: INO-108
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Overall response

  Complete response + very good partial response + partial response

  Day 29 post inclusion

Study Arms (1)

Inolimomab/Leukotac

EXPERIMENTAL

* 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

Biological: Inolimomab (Leukotac)

Interventions

Inolimomab (Leukotac) 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.

Inolimomab/Leukotac

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ElsaLys Biotech: lead

MeSH Terms

Interventions

inolimomab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2024
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share