A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
ACUTE LYMPHOBLASTIC LEUKEMIA
About this trial
This is an interventional treatment trial for ACUTE LYMPHOBLASTIC LEUKEMIA focused on measuring ALL, BCP ALL, High risk BCP ALL, Relapse ALL, Leukemia
Eligibility Criteria
Inclusion Criteria: Male or female participants between 1 and <18 years of age. 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 (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration) CD22-positive ALL as defined by local institution; Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status). 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; Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA. 5.2. Exclusion Criteria 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)]. Prior allo-HSCT or CAR T-cell therapy. Isolated extramedullary leukemia. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin). Participants with active, uncontrolled bacterial, fungal, or viral infection.
Sites / Locations
- UZ Gent
- UZ Leuven
- Cliniques Universitaires Saint-Luc
- Detska nemocnice FN Brno
- Fakultni nemocnice v Motole
- Helsinki university hospital
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
- CHU Strasbourg-Hautepierre
- Bordeaux University Hospital - Pellegrin
- Hôpital Arnaud de Villeneuve - CHU Montpellier
- Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De NantesRecruiting
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
- Hôpital Jeanne de Flandre
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo UniversitaRecruiting
- Institut d'Hématologie et d'Oncologie Pédiatrique
- Hôpital Armand Trousseau
- CHRU De Rennes - Hôpital Sud
- Universitaetsklinikum Tuebingen
- Universitaetsklinikum Ulm
- Universitaetsklinikum Wuerzburg
- Universitätsklinikum Frankfurt Goethe-Universität
- Medizinische Hochschule Hannover
- Universitätsklinikum Essen
- Universitätsklinikum Münster - Albert Schweitzer Campus
- Universitaetsklinikum Schleswig-Holstein Campus Kiel
- Charité Campus Virchow-Klinikum
- Universitätsklinikum Gießen
- Universitaetsklinikum Hamburg-Eppendorf
- Medizinische Hochschule Hannover
- Universitätsklinikum Jena
- Aghia Sophia Children's Hospital
- Pécsi Tudományegyetem Klinikai Központ
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
- Semmelweis Egyetem
- Schneider Children's Medical Center
- The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
- Rambam Health Care Campus
- Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
- Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
- IRCCS Istituto Giannina Gaslini
- Ospedale Pediatrico Bambino Gesù IRCCSRecruiting
- Policlinico "G. Rodolico"
- IRCCS - AOU di Bologna
- Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
- Fondazione IRCCS Policlinico San Matteo
- Ospedale Infantile Burlo Garofolo
- Prinses Maxima Centrum voor Kinderoncologie
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
- Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy
- Narodny ustav detskych chorob
- CHUS - Hospital Clinico Universitario
- Hospital Universitari Vall d'Hebron
- Hospital Sant Joan de Déu
- Hospital Infantil Universitario Niño Jesús
- Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
- Hospital Universitario La Paz
- CHUS - Hospital Clinico Universitario
- Hospital Universitario Virgen Del RocioRecruiting
- CHUV (centre hospitalier universitaire vaudois)
- Kinderspital Zürich
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Inotuzumab ozogamicin
ALLR3
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
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