NCT05748171Recruiting
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Summary
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 criteria
1. Male or female participants between 1 and \<18 years of age. 2. 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). 3. 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; 4. Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines. 5. 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 1. Any history of prior or ongoing hepatic SOS or prior liver failure \[defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)\]. 2. Prior allo-HSCT or CAR T-cell therapy. 3. Isolated extramedullary leukemia. 4. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present. 5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin). 6. Participants with active, uncontrolled bacterial, fungal, or viral infection. 7. Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP
Exclusion criteria
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, Belgium, Czechia, Denmark, Finland, Israel, Netherlands, Norway, Slovakia, Spain, Sweden
- Sponsor
- Pfizer(Industry)
- Protocol no.
- B1931036
- Conditions
- ACUTE LYMPHOBLASTIC LEUKEMIA
- Interventions
- Drug
Treatments studied
- Inotuzumab ozogamicin
- ALLR3
Locations · 65
- Bern, SwitzerlandInselspital BernRecruiting at this site
- Lausanne, SwitzerlandCHUV (centre hospitalier universitaire vaudois)Recruiting at this site
- Zurich, SwitzerlandKinderspital ZürichRecruiting at this site
- Nice, FranceCentre Hospitalier Universitaire de Nice - Hôpital l'ArchetRecruiting at this site
- Strasbourg, FranceCHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3Recruiting at this site
- Bordeaux, FranceBordeaux University Hospital - PellegrinRecruiting at this site
- Toulouse, FranceCHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-OncologieRecruiting at this site
- Vandœuvre-lès-Nancy, FranceCentre Hospitalier Régional Universitaire de Nancy - Hôpitaux de BraboisRecruiting at this site
- Lille, FranceHôpital Jeanne de Flandre - CHRURecruiting at this site
- Paris, FranceAssistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo UniversitaRecruiting at this site
- Lyon, FranceInstitut d'Hématologie et d'Oncologie PédiatriqueRecruiting at this site
- Nantes, FranceCHU de Nantes - Hôpital Mère - EnfantsRecruiting at this site
- Paris, FranceHôpital Armand TrousseauRecruiting at this site
- Rennes, FranceCHRU De Rennes - Hôpital SudRecruiting at this site
- Freiburg im Breisgau, GermanyUniversitaetsklinikum FreiburgRecruiting at this site
- Ulm, GermanyUniversitaetsklinikum UlmRecruiting at this site
- Würzburg, GermanyUniversitaetsklinikum WuerzburgRecruiting at this site
- Frankfurt am Main, GermanyUniversitätsklinikum Frankfurt Goethe-UniversitätRecruiting at this site
- Hanover, GermanyMedizinische Hochschule HannoverRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Münster, GermanyUniversitätsklinikum Münster - Albert Schweitzer CampusRecruiting at this site
- Kiel, GermanyUniversitaetsklinikum Schleswig-Holstein Campus KielRecruiting at this site
- Berlin, GermanyCharité Campus Virchow-KlinikumRecruiting at this site
- Düsseldorf, GermanyUniversitaetsklinikum DuesseldorfRecruiting at this site
- Giessen, GermanyUniversitätsklinikum GießenRecruiting at this site
- Hamburg, GermanyUniversitaetsklinikum Hamburg-EppendorfRecruiting at this site
- Hanover, GermanyMedizinische Hochschule HannoverRecruiting at this site
- Jena, GermanyUniversitätsklinikum JenaRecruiting at this site
- Naples, ItalyAzienda Ospedaliera di Rilievo Nazional Santobono PausiliponRecruiting at this site
- Genoa, ItalyIRCCS Istituto Giannina GasliniRecruiting at this site
In total, worldwide, all 65 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 24, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 35 more locations
Other identifiers
- 2023-509810-13-00 · other registry
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.