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 (Sep 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) 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 expression
Required: HYPODIPLOIDY hypodiploidy (<40 chromosomes) or masked low hypodiploidy
Required: KMT2A (MLL) kmt2a::aff1 fusion
Required: TCF3 tcf3-hlf fusion
Required: TCF3 tcf3-pbx1 fusion
Required: TP53 alteration
Excluded: ABL1 bcr-abl1 fusion
Disease stage
Required: Stage FIRST RELAPSE
Demographics
Prior therapy
Cannot have received: allogeneic stem cell transplant
Cannot have received: car-t cell therapy
Cannot have received: calicheamicin-conjugated antibody (inotuzumab ozogamicin, 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
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 stem cell transplant, car-t cell therapy, calicheamicin-conjugated antibody disqualifies patients from enrollment.
Does this trial require CD22?
Yes, CD22 expression is a required biomarker for enrollment.
Does this trial require HYPODIPLOIDY?
Yes, HYPODIPLOIDY hypodiploidy (<40 chromosomes) or masked low hypodiploidy is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A kmt2a::aff1 fusion is a required biomarker for enrollment.
Are patients with ABL1 alterations eligible?
No. ABL1 bcr-abl1 fusion is an exclusion criterion.
What disease stage is eligible?
Stage FIRST RELAPSE is required.
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.
Check if I qualify