NCT04289103

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: ElsaLys Biotech · Industry
• Sex: All
• Age: 28 Days – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-01
• Completion: 2024-06-01
• First posted: 2020-02-28
• Last updated: 2020-12-17

Regulatory

• FDA-regulated drug study