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

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 17, 2023

Primary Completion Date

October 31, 2033

Study Completion Date

November 4, 2036

Conditions
ACUTE LYMPHOBLASTIC LEUKEMIA
Interventions
DRUG

Inotuzumab ozogamicin

Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved in several countries for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle.

DRUG

ALLR3

The ALLR3 chemotherapy regimen (vincristine, mitoxantrone, dexamethasone, and PEG-asparaginase \[or erwinia-asparaginase in the event of an allergic reaction to PEG-asparaginase\]) has been adopted by pediatric oncology groups as treatment for pediatric relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL)

Trial Locations (74)

1011

RECRUITING

CHUV (centre hospitalier universitaire vaudois), Lausanne

1090

RECRUITING

St. Anna Kinderspital, Vienna

1094

RECRUITING

Semmelweis Egyetem, Budapest

1200

RECRUITING

Cliniques universitaires Saint-Luc, Brussels

3000

RECRUITING

UZ Leuven, Leuven

3010

RECRUITING

Inselspital Bern, Bern

3526

RECRUITING

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc

7623

RECRUITING

Pécsi Tudományegyetem Klinikai Központ, Pécs

8008

RECRUITING

Kinderspital Zürich, Zurich

9000

RECRUITING

UZ Gent, Ghent

10126

RECRUITING

Ospedale Regina Margherita, Torino

13353

RECRUITING

Charité Campus Virchow-Klinikum, Berlin

15706

RECRUITING

CHUS - Hospital Clinico Universitario, Santiago de Compostela

RECRUITING

CHUS - Hospital Clinico Universitario, Santiago de Compostela

16147

RECRUITING

IRCCS Istituto Giannina Gaslini, Genoa

17067

RECRUITING

Astrid Lindgrens Barnsjukhus, Stockholm

20246

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

22185

RECRUITING

Skånes Universitetssjukhus Lund, Lund

24105

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel

27100

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

28009

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

30120

RECRUITING

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

RECRUITING

Medizinische Hochschule Hannover, Hanover

31059

RECRUITING

CHU de Toulouse - Hôpital des Enfants, Toulouse

33076

RECRUITING

Bordeaux University Hospital - Pellegrin, Bordeaux

34090

RECRUITING

Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier

34137

RECRUITING

Ospedale Infantile Burlo Garofolo, Trieste

35128

RECRUITING

Azienda Ospedale - Università Padova, Padua

35203

RECRUITING

CHRU De Rennes - Hôpital Sud, Rennes

35392

RECRUITING

Universitätsklinikum Gießen, Giessen

40138

RECRUITING

IRCCS - AOU di Bologna, Bologna

40225

RECRUITING

Universitaetsklinikum Duesseldorf, Düsseldorf

41013

RECRUITING

Hospital Universitario Virgen Del Rocio, Seville

44000

RECRUITING

Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes, Nantes

45122

RECRUITING

Universitaetsklinikum Essen, Essen

46026

RECRUITING

Hospital Universitari i Politecnic La Fe, Valencia

48149

RECRUITING

Universitätsklinikum Münster - Albert Schweitzer Campus, Münster

49202

RECRUITING

Schneider Children's Medical Center, Petah Tikva

54511

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois, Vandœuvre-lès-Nancy

59037

RECRUITING

Hôpital Jeanne de Flandre, Lille

60590

RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt am Main

67098

RECRUITING

CHU Strasbourg-Hautepierre, Strasbourg

69008

RECRUITING

Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon

72076

RECRUITING

Universitaetsklinikum Tuebingen, Tübingen

75571

RECRUITING

Hôpital Armand Trousseau, Paris

75935

RECRUITING

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita, Paris

79106

RECRUITING

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80123

RECRUITING

Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon, Napoli

89081

RECRUITING

Universitaetsklinikum Ulm, Ulm

90127

RECRUITING

Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli, Palermo

95123

RECRUITING

"Policlinico G. Rodolico", Catania

97080

RECRUITING

Universitaetsklinikum Wuerzburg, Würzburg

3109601

RECRUITING

Rambam Health Care Campus, Haifa

5265601

RECRUITING

The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric, Ramat Gan

6423906

RECRUITING

Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital, Tel Aviv

613 00

RECRUITING

Detska nemocnice FN Brno, Brno

150 06

RECRUITING

Fakultni nemocnice v Motole, Prague

DK-2100

RECRUITING

Rigshospitalet, Copenhagen

00290

RECRUITING

Helsinki university hospital, Helsinki

06202

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet, Nice

07747

RECRUITING

Universitätsklinikum Jena, Jena

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS, Rome

3584 CS

RECRUITING

Prinses Maxima Centrum voor Kinderoncologie, Utrecht

0372

RECRUITING

Oslo Universitetssykehus Rikshospitalet, Oslo

0379

RECRUITING

Radium Hospital, Oslo

85-094

RECRUITING

Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy, Bydgoszcz

50-556

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wroclaw

833 40

RECRUITING

Narodny ustav detskych chorob, Bratislava

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08950

RECRUITING

Hospital Sant Joan de Déu, Esplugues de Llobregat

416 85

RECRUITING

Sahlgrenska Universitetssjukhuset Östra, Gothenburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY