Actively Recruiting
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Led by Pfizer · Updated on 2026-05-14
100
Participants Needed
76
Research Sites
702 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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) or very high risk (VHR) 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.
CONDITIONS
Official Title
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants between 1 and under 18 years of age
- Confirmed first relapse high-risk or very high-risk B-cell precursor acute lymphoblastic leukemia
- CD22-positive leukemia with bone marrow involvement of 5% or more leukemic blasts
- Adequate kidney function (eGFR or eCrCl ≥ 30 mL/min) appropriate for age
- Liver function with AST and ALT levels ≤ 5 times institutional upper limit of normal
- Total bilirubin ≤ 1.5 times institutional upper limit of normal unless Gilbert's syndrome is present
- Prior thrombosis during corticosteroid or asparaginase use allowed if receiving anticoagulant prophylaxis
- Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction > 50% by MUGA
- Participants with combined bone marrow and testicular relapse eligible if orchiectomy done or planned
You will not qualify if you...
- History of prior or ongoing hepatic sinusoidal obstruction syndrome or liver failure
- Previous allogeneic stem cell transplant or CAR T-cell therapy
- Isolated extramedullary leukemia
- Philadelphia-chromosome positive ALL (BCR-ABL/t(9;22))
- Prior therapy with calicheamicin-conjugated antibodies (e.g., InO or gemtuzumab ozogamicin)
- Active, uncontrolled bacterial, fungal, or viral infection
- Allergy or hypersensitivity to both PEG-asparaginase and erwinia-asparaginase
AI-Screening
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Trial Site Locations
Total: 76 locations
1
St. Anna Kinderspital
Vienna, Austria, 1090
Actively Recruiting
2
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, Belgium, 1200
Actively Recruiting
3
UZ Gent
Ghent, Oost-vlaanderen, Belgium, 9000
Actively Recruiting
4
UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000
Actively Recruiting
5
Detska nemocnice FN Brno
Brno, Brno-město, Czechia, 613 00
Actively Recruiting
6
Fakultni Nemocnice Motol a Homolka
Prague, Czechia, 150 00
Actively Recruiting
7
Rigshospitalet
Copenhagen, Capital Region, Denmark, DK-2100
Actively Recruiting
8
Helsinki university hospital
Helsinki, Finland, 00290
Actively Recruiting
9
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-maritimes, France, 06202
Actively Recruiting
10
CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3
Strasbourg, Alsace, France, 67000
Actively Recruiting
11
Bordeaux University Hospital - Pellegrin
Bordeaux, Aquitaine, France, 33076
Actively Recruiting
12
CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-Oncologie
Toulouse, Haute-garonne, France, 31059
Actively Recruiting
13
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, France, 34090
Actively Recruiting
14
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-moselle, France, 54511
Actively Recruiting
15
Hôpital Jeanne de Flandre - CHRU
Lille, NORD, France, 59037
Actively Recruiting
16
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, Paris, France, 75935
Actively Recruiting
17
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69008
Actively Recruiting
18
CHU de Nantes - Hôpital Mère - Enfants
Nantes, France, 44000
Actively Recruiting
19
Hôpital Armand Trousseau
Paris, France, 75571
Actively Recruiting
20
CHRU De Rennes - Hôpital Sud
Rennes, France, 35203
Actively Recruiting
21
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
22
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
23
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
24
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
25
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
26
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
27
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45122
Actively Recruiting
28
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
29
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
30
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Actively Recruiting
31
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
32
Universitätsklinikum Gießen
Giessen, Germany, 35392
Actively Recruiting
33
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
34
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
35
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
36
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary, 7623
Actively Recruiting
37
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
Actively Recruiting
38
Semmelweis Egyetem
Budapest, Hungary, 1094
Actively Recruiting
39
Medanta - The Medicity
Gurugram, Haryana, India, 122001
Not Yet Recruiting
40
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, India, 110085
Not Yet Recruiting
41
Schneider Children's Medical Center
Petah Tikva, Central District, Israel, 49202
Actively Recruiting
42
The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
43
Rambam Health Care Campus
Haifa, Northern District, Israel, 3109601
Actively Recruiting
44
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
Tel Aviv, TELL ABĪB, Israel, 6423906
Actively Recruiting
45
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
Naples, Campania, Italy, 80123
Actively Recruiting
46
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy, 16147
Actively Recruiting
47
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Actively Recruiting
48
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, ROMA, Italy, 00165
Actively Recruiting
49
Policlinico "G. Rodolico"
Catania, Sicily, Italy, 95123
Actively Recruiting
50
Azienda Ospedale - Università Padova
Padova, Veneto, Italy, 35128
Actively Recruiting
51
IRCCS - AOU di Bologna
Bologna, Italy, 40138
Actively Recruiting
52
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, Italy, 90127
Actively Recruiting
53
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
54
Ospedale Regina Margherita
Torino, Italy, 10126
Actively Recruiting
55
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, 34137
Actively Recruiting
56
Prinses Maxima Centrum voor Kinderoncologie
Utrecht, Netherlands, 3584 CS
Actively Recruiting
57
Oslo Universitetssykehus Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
58
Radium Hospital
Oslo, Norway, 0379
Actively Recruiting
59
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-094
Actively Recruiting
60
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
61
Narodny ustav detskych chorob
Bratislava, Bratislava Region, Slovakia, 833 40
Actively Recruiting
62
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
Actively Recruiting
63
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain, 08035
Actively Recruiting
64
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [barcelona], Spain, 08950
Actively Recruiting
65
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, Spain, 28009
Actively Recruiting
66
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
67
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
68
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Spain, 15706
Actively Recruiting
69
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
70
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
71
Skånes Universitetssjukhus Lund
Lund, Skåne LÄN [se-12], Sweden, 22185
Actively Recruiting
72
Sahlgrenska Universitetssjukhuset Östra
Gothenburg, Västra Götalands LÄN [se-14], Sweden, 416 85
Actively Recruiting
73
Astrid Lindgrens Barnsjukhus
Stockholm, Sweden, 17067
Actively Recruiting
74
Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
75
CHUV (centre hospitalier universitaire vaudois)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
76
Kinderspital Zürich
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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