A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Recruiting now · Phase 2

Conditions studied: ACUTE LYMPHOBLASTIC LEUKEMIA

In brief

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.

Key facts

Study ID

NCT05748171

Run by

Pfizer

People needed

100

Starts

2023-05-17

Expected to finish

2036-05-25

Last updated by the study team

2026-07-09

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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

Where it is running

• Cliniques universitaires Saint-Luc — Brussels, Bruxelles-capitale, Région de, Belgium (enrolling)
• UZ Gent — Ghent, Oost-vlaanderen, Belgium (enrolling)
• UZ Leuven — Leuven, Vlaams-brabant, Belgium (enrolling)
• Detska nemocnice FN Brno — Brno, Brno-město, Czechia (enrolling)
• Fakultni Nemocnice Motol a Homolka — Prague, Czechia (enrolling)
• Rigshospitalet — Copenhagen, Capital Region, Denmark (enrolling)
• Helsinki university hospital — Helsinki, Finland (enrolling)
• Centre Hospitalier Universitaire de Nice - Hôpital l'Archet — Nice, Alpes-maritimes, France (enrolling)
• CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3 — Strasbourg, Alsace, France (enrolling)
• Bordeaux University Hospital - Pellegrin — Bordeaux, Aquitaine, France (enrolling)
• CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-Oncologie — Toulouse, Haute-garonne, France (enrolling)
• Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier, Hérault, France (enrolling)
• Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy, Meurthe-et-moselle, France (enrolling)
• Hôpital Jeanne de Flandre - CHRU — Lille, NORD, France (enrolling)
• Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita — Paris, Paris, France (enrolling)
• Institut d'Hématologie et d'Oncologie Pédiatrique — Lyon, France (enrolling)
• CHU de Nantes - Hôpital Mère - Enfants — Nantes, France (enrolling)
• Hôpital Armand Trousseau — Paris, France (enrolling)
• CHRU De Rennes - Hôpital Sud — Rennes, France (enrolling)
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsklinikum Wuerzburg — Würzburg, Bavaria, Germany (enrolling)
• Universitätsklinikum Frankfurt Goethe-Universität — Frankfurt am Main, Hesse, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany (enrolling)
• St. Anna Kinderspital — Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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