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

PHASE3UnknownINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

October 31, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

June 30, 2024

Conditions
Steroid Refractory GVHD
Interventions
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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ElsaLys Biotech

INDUSTRY