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Brief Title: A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Official Title: 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 FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA
Study ID: NCT05748171
Brief 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) 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.
Detailed 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 HR 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 for efficacy and safety will continue for up to 5 years from randomization. End of Treatment is defined as occurring upon recovery from 1 cycle of study therapy (Day 28 ± 2 days), or one day before initiation of new anticancer therapy, whichever occurs first. Approximately 100 participants will be randomized (2:1) to receive 1 cycle of either InO monotherapy or ALLR3 (block 1) therapy during induction. After completion of induction therapy (ie, study therapy), it is anticipated that the majority of responding participants will proceed immediately to consolidation therapy. Non-responders are expected to proceed with salvage therapy at the investigator's discretion. Participants responding to induction therapy are expected to proceed to SOC consolidation therapy upon recovery of blood counts, but no sooner than 7 days after last dose of study intervention. All participants (responders and non-responders) will proceed to long-term follow-up for this study. All subsequent anticancer therapy will be determined by the treating physician.
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
St. Anna Kinderspital, Vienna, , Austria
Cliniques universitaires Saint-Luc, Brussels, Bruxelles-capitale, Région DE, Belgium
UZ Gent, Gent, Oost-vlaanderen, Belgium
UZ Leuven, Leuven, Vlaams-brabant, Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Detska nemocnice FN Brno, Brno, Brno-město, Czechia
Fakultni nemocnice v Motole, Prague, , Czechia
Rigshospitalet, Copenhagen, Hovedstaden, Denmark
Helsinki university hospital, Helsinki, , Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet, Nice, Alpes-maritimes, France
CHU Strasbourg-Hautepierre, Strasbourg, Alsace, France
Bordeaux University Hospital - Pellegrin, Bordeaux, Aquitaine, France
CHU de Toulouse - Hôpital des Enfants, Toulouse, Haute-garonne, France
Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier, Hérault, France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes, Nantes, Loire-atlantique, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois, Vandoeuvre lès Nancy, Meurthe-et-moselle, France
Hôpital Jeanne de Flandre, Lille, Nord, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita, Paris Cedex 19, Paris, France
Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon, , France
Hôpital Armand Trousseau, Paris, , France
CHRU De Rennes - Hôpital Sud, Rennes, , France
Universitaetsklinikum Freiburg, Freiburg, Baden-württemberg, Germany
Universitaetsklinikum Tuebingen, Tübingen, Baden-württemberg, Germany
Universitaetsklinikum Ulm, Ulm, Baden-württemberg, Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, Bayern, Germany
Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-westfalen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus, Münster, Nordrhein-westfalen, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel, Schleswig-holstein, Germany
Charité Campus Virchow-Klinikum, Berlin, , Germany
Universitaetsklinikum Duesseldorf, Düsseldorf, , Germany
Universitätsklinikum Gießen, Giessen, , Germany
Universitätsklinikum Gießen, Giessen, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Jena, Jena, , Germany
Aghia Sophia Children's Hospital, Athens, Attikí (region), Greece
Pécsi Tudományegyetem Klinikai Központ, Pécs, Baranya, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc, Borsod-abaúj-zemplén, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Schneider Children's Medical Center, Petah-Tikva, Hamerkaz, Israel
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric, Ramat Gan, Hamerkaz, Israel
Rambam Health Care Campus, Haifa, Hatsafon, Israel
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital, Tel Aviv, Tell Abīb, Israel
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon, Napoli, Campania, Italy
IRCCS Istituto Giannina Gaslini, Genova, Liguria, Italy
Fondazione MBBM - Ematologia Pediatrica, Monza, Monza E Brianza, Italy
Ospedale Pediatrico Bambino Gesù IRCCS, Rome, Roma, Italy
Policlinico "G. Rodolico", Catania, Sicilia, Italy
Azienda Ospedale - Università Padova, Padova, Veneto, Italy
IRCCS - AOU di Bologna, Bologna, , Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli, Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Ospedale Regina Margherita, Torino, , Italy
Ospedale Infantile Burlo Garofolo, Trieste, , Italy
Prinses Maxima Centrum voor Kinderoncologie, Utrecht, , Netherlands
Oslo Universitetssykehus Rikshospitalet, Oslo, , Norway
Radium Hospital, Oslo, , Norway
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wrocław, Dolnośląskie, Poland
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy, Bydgoszcz, Kujawsko-pomorskie, Poland
Narodny ustav detskych chorob, Bratislava, Bratislavský KRAJ, Slovakia
CHUS - Hospital Clinico Universitario, Santiago de Compostela, A Coruña [LA Coruña], Spain
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain
Hospital Sant Joan de Déu, Esplugues de Llobregat, Barcelona [barcelona], Spain
Hospital Infantil Universitario Niño Jesús, Madrid, Madrid, Comunidad DE, 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, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Skånes Universitetssjukhus Lund, Lund, Skåne LÄN [se-12], Sweden
Sahlgrenska Universitetssjukhuset Östra, Gothenburg, Västra Götalands LÄN [se-14], Sweden
Astrid Lindgrens Barnsjukhus, Stockholm, , Sweden
Inselspital Bern, Bern, Berne, Switzerland
CHUV (centre hospitalier universitaire vaudois), Lausanne, Vaud, Switzerland
Kinderspital Zürich, Zürich, , Switzerland
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR