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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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