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RECRUITING

NCT05748171

PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-05-17

Completion Date

2036-11-04

Last Updated

2026-03-20

Healthy Volunteers

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)

Inclusion Criteria: 1. Male or female participants between 1 and \<18 years of age. 2. Morphologically confirmed diagnosis of first relapse HR 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). * CD22-positive ALL as defined by local institution; * Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status). 3. 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; * Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome; 4. Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines. 5. 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 1. Any history of prior or ongoing hepatic SOS or prior liver failure \[defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)\]. 2. Prior allo-HSCT or CAR T-cell therapy. 3. Isolated extramedullary leukemia. 4. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present. 5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin). 6. Participants with active, uncontrolled bacterial, fungal, or viral infection. 7. Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP

Locations (76)

St. Anna Kinderspital

Vienna, Austria

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-capitale, Région de, Belgium

UZ Gent

Ghent, Oost-vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Detska nemocnice FN Brno

Brno, Brno-město, Czechia

Fakultni Nemocnice Motol a Homolka

Prague, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Helsinki university hospital

Helsinki, Finland

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, Alpes-maritimes, France

CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3

Strasbourg, Alsace, France

Bordeaux University Hospital - Pellegrin

Bordeaux, Aquitaine, France

CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-Oncologie

Toulouse, Haute-garonne, France

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-moselle, France

Hôpital Jeanne de Flandre - CHRU

Lille, NORD, France

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

Paris, 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, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, Germany

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 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

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, Borsod-Abauj Zemplen county, Hungary

Semmelweis Egyetem

Budapest, Hungary

Medanta - The Medicity

Gurugram, Haryana, India

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, India

Schneider Children's Medical Center

Petah Tikva, Central District, Israel

The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center

Ramat Gan, Central District, Israel

Rambam Health Care Campus

Haifa, Northern District, Israel

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

Tel Aviv, TELL ABĪB, Israel

Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon

Naples, Campania, Italy

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, ROMA, Italy

Policlinico "G. Rodolico"

Catania, Sicily, 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

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, Kuyavian-Pomeranian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

Narodny ustav detskych chorob

Bratislava, Bratislava Region, 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, Murcia, 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, Skåne LÄN [se-12], Sweden

Sahlgrenska Universitetssjukhuset Östra

Gothenburg, Västra Götalands LÄN [se-14], Sweden

Astrid Lindgrens Barnsjukhus

Stockholm, Sweden

Inselspital Bern

Bern, Canton of Bern, Switzerland

CHUV (centre hospitalier universitaire vaudois)

Lausanne, Canton of Vaud, Switzerland

Kinderspital Zürich

Zurich, Switzerland