A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
NCT ID: NCT05748171
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2023-05-17
2036-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inotuzumab ozogamicin
Each participant in the InO arm will receive 1 course (3 doses) of InO, as follows:
* Day 1: 0.8 mg/m2
* Days 8 (±1 day) and Day 15 (±1 day): 0.5 mg/m2/dose
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.
ALLR3
Mitoxantrone 10 mg/m2 on Days 1 and 2 Vincristine 1.5 mg/m2 (max single dose 2 mg) administered on Days 3, 10, 17 and 24 Dexamethasone 20 mg/m2/day administered orally (or IV) divided into two daily doses (maximum 40 mg/day) as two 5-day blocks on Days 1-5 and Days 15-19.
PEG-asparaginase 1000 units/m2 IV administered on Days 3 and 17. In case of hypersensitivity/allergic reaction to PEG-asparaginase, each dose of PEG-asparaginase will be replaced by Erwinia-asparaginase at a dose of 20,000 units/m² IV or IM every other day for a total of 6 doses
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)
Interventions
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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.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
1 Year
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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 v Motole
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 Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes
Nantes, Loire-atlantique, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-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, 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 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
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
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
Napoli, 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
Padua, 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
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, , 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
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-509810-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B1931036
Identifier Type: -
Identifier Source: org_study_id