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 (Jun 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
Treatments studied
Targeted therapy
Other
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
Demographics
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.
Frequently asked questions
Is NCT05748171 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant, CAR-T cell therapy, calicheamicin-conjugated antibody disqualifies patients from enrollment.
Does this trial require CD22?
Yes, CD22 overexpression is a required biomarker for enrollment.
Are patients with KMT2A alterations eligible?
No. KMT2A KMT2A::AFF1 fusion is an exclusion criterion.
Are patients with TCF3 alterations eligible?
No. TCF3 TCF3-HLF fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 17 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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