NCT05748171RecruitingPhase 2
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 Jan 2023
- Start date
- 17 May 2023
- Primary completion date
- 21 May 2033
- Lead sponsor
- Pfizer
- NCT number
- NCT05748171
- EU CT number
- 2023-509810-13-00
- EudraCT number
- 2022-000186-40
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 17 May 2023 to the primary completion date, 21 May 2033
- 72 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anna Kinderspital GmbH Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Universiteit Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| CHUV (centre hospitalier universitaire vaudois) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Universidade De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago De Compostela | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| CHU de Bordeaux - Hôpital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Hôpital Jeanne de Flandre Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP) Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hôpital Archet 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Robert Debre University Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Trousseau Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| CHU Nancy - Hôpital Brabois Coordinator of this site? Confirm its status | Vandoeuvre lès Nancy | France | Recruiting |
| Aghia Sophia' Children's Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Miskolc | Hungary | Completed |
| Pécsi Tudományegyetem Klinikai Központ Coordinator of this site? Confirm its status | - | Hungary | Completed |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Fondazione MBBM - Ematologia Pediatrica Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliera Santobono Pausilipon Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| ARNAS Civico Di Cristina Benfratelli Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedale Infantile Regina Margherita Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Sahlgrenska Universitetssjukhuset, Östra Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Narodny ustav detskych chorob Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.