Tests inotuzumab ozogamicin in children with first relapse of acute lymphoblastic leukemia
Compares inotuzumab ozogamicin with standard ALLR3 treatment in children with relapsed leukemia.
Plain-language title generated from the registry record
Registry title: A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 1 to under 18 with CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) that has come back for the first time, at high or very high risk.
- Age
- 1 to under 18 years
- Sex
- Boys and girls can both join.
- Disease stage
- First relapse of high-risk or very high-risk B-cell precursor ALL, with CD22-positive leukaemia and at least 5% leukaemia cells in the bone marrow.
- Earlier treatment
- Children who have had a stem cell transplant from a donor, CAR T-cell therapy, or a calicheamicin-linked antibody such as inotuzumab ozogamicin or gemtuzumab ozogamicin cannot join.
- Biomarker or test result
- The leukaemia must be CD22-positive. Philadelphia-chromosome positive ALL (BCR-ABL/t(9;22)) is not allowed.
Main reasons for not taking part
- Past or current liver sinusoidal obstruction syndrome (SOS) or liver failure
- Leukaemia only outside the bone marrow
- Philadelphia-chromosome positive ALL
- Active infection that is not under control
- Allergy to both PEG-ASP and Erwinia-ASP
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 17 years old?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
Source: NCT05748171, who can take part
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Pfizer
- Trial code
- NCT05748171EU 2023-509810-13-00
- Record updated
- 24 September 2026
- Original description
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.Read full original descriptionShow less
A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH-RISK OR VERY HIGH-RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA
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.
Inclusion: Male or female participants between 1 and <18 years of age; Morphologically confirmed diagnosis of first relapse HR or VHR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion [t(4;11)(q21;q23)], TCF3-HLF fusion [t(17;19)(q22;p13)], TCF3-PBX1 fusion [t(1;19)(q23;p13.3)], hypodiploidy [<40 chromosomes] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration). VHR first relapse is defined as relapse within 18 months of original diagnosis of ALL and/or with any of the following genetic abnormalities at original diagnosis or at relapse (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion [t(4;11)(q21;q23)], TCF3-HLF fusion [t(17;19)(q22;p13)], TCF3-PBX1 fusion [t(1;19)(q23;p13.3)], hypodiploidy [<40 chromosomes] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration); CD22-positive ALL as defined by local institution; Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status); Adequate serum chemistry parameters:; An eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2; AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia; (Refer to Appendix 9 for France-specific requirement on the ALT/AST threshold); Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome; Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines; Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA; 6 Participants with combined bone marrow and testicular relapse are eligible assuming orchiectomy is performed prior to randomization or is planned at the end of induction therapy; 5.2. Exclusion Criteria; Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)]; Prior allo-HSCT or CAR T-cell therapy; Isolated extramedullary leukemia; Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present; Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin); Participants with active, uncontrolled bacterial, fungal, or viral infection; Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP.