HomeTrialNCT05748171
🔬NCT05748171Phase 2RECRUITING

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Study Summary

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \<18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment100 participants
Primary Completion
Lead SponsorPfizer
Data Retrieved2026-04-11 02:55:53.191019+00:00
Not financial advice. BiotechSigns data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.