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Study identifier: NCT05748171 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: ACUTE LYMPHOBLASTIC LEUKEMIA  ·  Sponsor: Pfizer

PhasePhase 2
Planned participants100
Who can joinAll sexes, 1 Year to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Pfizer CT.gov Call Center  ·  1-800-718-1021  ·  ClinicalTrials.gov_Inquiries@pfizer.com

Always discuss trial participation with your own doctor first.

Locations (68)

St. Anna KinderspitalVienna, AustriaRecruiting
Cliniques universitaires Saint-LucBrussels, Bruxelles-capitale, Région de, BelgiumRecruiting
UZ GentGhent, Oost-vlaanderen, BelgiumRecruiting
UZ LeuvenLeuven, Vlaams-brabant, BelgiumRecruiting
Detska nemocnice FN BrnoBrno, Brno-město, CzechiaRecruiting
Fakultni Nemocnice Motol a HomolkaPrague, CzechiaRecruiting
RigshospitaletCopenhagen, Capital Region, DenmarkRecruiting
Helsinki university hospitalHelsinki, FinlandRecruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'ArchetNice, Alpes-maritimes, FranceRecruiting
CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3Strasbourg, Alsace, FranceRecruiting
Bordeaux University Hospital - PellegrinBordeaux, Aquitaine, FranceRecruiting
CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-OncologieToulouse, Haute-garonne, FranceRecruiting

+ 56 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05748171