Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
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) or very high risk (VHR) 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.
Protocol Amendment History 3 changes
notable Trial sites reduced: 74 -> 68 locations 2026-07-10
notable Primary completion moved earlier: 2033-10-31 -> 2033-05-21 2026-07-10
minor Completion moved earlier: 2036-11-04 -> 2036-05-25 2026-07-10
Trial Details
NCT Number NCT05748171
Lead Sponsor Pfizer
Conditions ACUTE LYMPHOBLASTIC LEUKEMIA
Enrollment 100 participants
Start Date 2023-05-17
Primary Completion 2033-05-21 (estimated)
Study Completion 2036-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-09