A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dziewczęta i chłopcy w wieku od 1 roku do poniżej 18 lat
- •Pierwszy nawrót białaczki typu ALL o wysokim ryzyku, potwierdzonony badaniem szpiku kostnego
- •Komórki nowotworowe muszą być CD22-dodatnie
- •Co najmniej 5% złośliwych komórek w szpiku kostnym
- •Prawidłowe funkcjonowanie nerek (eGFR lub eCrCl ≥30 mL/min)
- •Prawidłowe funkcjonowanie wątroby (enzymy transaminazy i bilirubina w normie)
- •Prawidłowe funkcjonowanie serca (frakcja skracania ≥30% lub frakcja wyrzutowa >50%)
- •Jeśli było wcześniej zakrzepowe podczas stosowania kortykosteroidów, można uczestniczyć jeśli przyjmuje się leki zapobiegające zakrzepom
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Maximum age
- 17 Years
- Last updated (source)
- July 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (68)
St. Anna Kinderspital
Vienna, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Detska nemocnice FN Brno
Brno, Czechia
Fakultni Nemocnice Motol a Homolka
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Helsinki university hospital
Helsinki, Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France
CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3
Strasbourg, France
Bordeaux University Hospital - Pellegrin
Bordeaux, France
CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-Oncologie
Toulouse, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
Hôpital Jeanne de Flandre - CHRU
Lille, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, France
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France
CHU de Nantes - Hôpital Mère - Enfants
Nantes, France
Hôpital Armand Trousseau
Paris, France
CHRU De Rennes - Hôpital Sud
Rennes, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Universitätsklinikum Gießen
Giessen, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Schneider Children's Medical Center
Petah Tikva, Israel
The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
Ramat Gan, Israel
Rambam Health Care Campus
Haifa, Israel
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
Tel Aviv, Israel
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
Naples, Italy
IRCCS Istituto Giannina Gaslini
Genoa, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Italy
Policlinico "G. Rodolico"
Catania, Italy
Azienda Ospedale - Università Padova
Padova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Ospedale Regina Margherita
Torino, Italy
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy
Prinses Maxima Centrum voor Kinderoncologie
Utrecht, Netherlands
Oslo Universitetssykehus Rikshospitalet
Oslo, Norway
Radium Hospital
Oslo, Norway
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy
Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland
Narodny ustav detskych chorob
Bratislava, Slovakia
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Spain
Hospital Universitario La Paz
Madrid, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Skånes Universitetssjukhus Lund
Lund, Sweden
Sahlgrenska Universitetssjukhuset Östra
Gothenburg, Sweden
Astrid Lindgrens Barnsjukhus
Stockholm, Sweden
Inselspital Bern
Bern, Switzerland
CHUV (centre hospitalier universitaire vaudois)
Lausanne, Switzerland
Kinderspital Zürich
Zurich, Switzerland
Trial contact
Pfizer CT.gov Call Center
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
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