OncoMatch/Clinical Trials/NCT05748171
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Is NCT05748171 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Inotuzumab ozogamicin and ALLR3 for acute lymphoblastic leukemia.
Treatment: Inotuzumab ozogamicin · ALLR3 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 overexpression (CD22-positive ALL as defined by local institution)
CD22-positive ALL as defined by local institution
Excluded: KMT2A (MLL) KMT2A::AFF1 fusion
lacking any identified very high-risk genetic abnormalities (ie, KMT2A::AFF1 fusion [t(4;11)(q21;q23)])
Excluded: TCF3 TCF3-HLF fusion
lacking any identified very high-risk genetic abnormalities (ie, ... TCF3-HLF fusion [t(17;19)(q22;p13)])
Excluded: TCF3 TCF3-PBX1 fusion
lacking any identified very high-risk genetic abnormalities (ie, ... TCF3-PBX1 fusion [t(1;19)(q23;p13.3)])
Excluded: TP53 alteration
lacking any identified very high-risk genetic abnormalities (ie, ... TP53 alteration)
Excluded: BCR BCR-ABL fusion
Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior allo-HSCT
Cannot have received: CAR-T cell therapy
Prior ... CAR T-cell therapy
Cannot have received: calicheamicin-conjugated antibody (inotuzumab ozogamicin, gemtuzumab ozogamicin)
Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin)
Lab requirements
Kidney function
eGFR (1 to <2 years) or eCrCl (2 to <18 years) ≥30 mL/min
Liver function
AST and ALT ≤5 × institutional ULN; total bilirubin ≤1.5 × institutional ULN unless Gilbert's syndrome
Cardiac function
shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA
Adequate serum chemistry parameters: eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min; AST and ALT ≤5 × institutional ULN; total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome; Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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