The EDC is live today — see what ships now
Trialion
All studies
NCT05748171From ClinicalTrials.govRecruiting

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

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 OR VERY HIGH-RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA

  • ACUTE LYMPHOBLASTIC LEUKEMIA

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Pfizer
Enrolment target
100
Started
17 May 2023
Main results due
21 May 2033
Study sites
65
Registry updated
24 September 2026

Can you take part?

  • Ages 1 year to 17 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Male or female participants between 1 and \<18 years of age.
2. Morphologically confirmed diagnosis of first relapse HR or VHR 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). VHR first relapse is defined as relapse within 18 months of original diagnosis of ALL and/or with any of the following genetic abnormalities at original diagnosis or at relapse (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; (Refer to Appendix 9 for France-specific requirement on the ALT/AST threshold);
   * 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(65)

  • St. Anna Kinderspital

    Vienna, Austria

    Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-capitale, Région de, Belgium

    Recruiting

  • UZ Gent

    Ghent, Oost-vlaanderen, Belgium

    Recruiting

  • UZ Leuven

    Leuven, Vlaams-brabant, Belgium

    Recruiting

  • Detska nemocnice FN Brno

    Brno, Brno-město, Czechia

    Recruiting

  • Fakultni Nemocnice Motol a Homolka

    Prague, Czechia

    Recruiting

  • Rigshospitalet

    Copenhagen, Capital Region, Denmark

    Recruiting

  • Helsinki university hospital

    Helsinki, Finland

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, Alpes-maritimes, France

    Recruiting

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

    Strasbourg, Alsace, France

    Recruiting

  • Bordeaux University Hospital - Pellegrin

    Bordeaux, Aquitaine, France

    Recruiting

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

    Toulouse, Haute-garonne, France

    Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

    Recruiting

  • Hôpital Jeanne de Flandre - CHRU

    Lille, NORD, France

    Recruiting

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

    Paris, Paris, France

    Recruiting

  • Institut d'Hématologie et d'Oncologie Pédiatrique

    Lyon, France

    Recruiting

  • CHU de Nantes - Hôpital Mère - Enfants

    Nantes, France

    Recruiting

  • Hôpital Armand Trousseau

    Paris, France

    Recruiting

  • CHRU De Rennes - Hôpital Sud

    Rennes, France

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, Germany

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, Germany

    Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, Bavaria, Germany

    Recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt am Main, Hesse, Germany

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, Germany

    Recruiting

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, Germany

    Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, Germany

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, Germany

    Recruiting

  • Charité Campus Virchow-Klinikum

    Berlin, Germany

    Recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, Germany

    Recruiting

  • Universitätsklinikum Gießen

    Giessen, Germany

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, Germany

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, Germany

    Recruiting

  • Universitätsklinikum Jena

    Jena, Germany

    Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, Central District, Israel

    Recruiting

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

    Ramat Gan, Central District, Israel

    Recruiting

  • Rambam Health Care Campus

    Haifa, Northern District, Israel

    Recruiting

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

    Tel Aviv, TELL ABĪB, Israel

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon

    Naples, Campania, Italy

    Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genoa, Liguria, Italy

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, Italy

    Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, ROMA, Italy

    Recruiting

  • Policlinico "G. Rodolico"

    Catania, Sicily, Italy

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova, Veneto, Italy

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Italy

    Recruiting

  • Ospedale Regina Margherita

    Torino, Italy

    Recruiting

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, Italy

    Recruiting

  • Prinses Maxima Centrum voor Kinderoncologie

    Utrecht, Netherlands

    Recruiting

  • Oslo Universitetssykehus Rikshospitalet

    Oslo, Norway

    Recruiting

  • Radium Hospital

    Oslo, Norway

    Recruiting

  • Narodny ustav detskych chorob

    Bratislava, Bratislava Region, Slovakia

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña], Spain

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], Spain

    Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [barcelona], Spain

    Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad de, Spain

    Recruiting

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, Spain

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Spain

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, Spain

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, Spain

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain

    Recruiting

  • Skånes Universitetssjukhus Lund

    Lund, Skåne LÄN [se-12], Sweden

    Recruiting

Showing 60 of 65 sites — filter to narrow it down. 65 of the 65 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05748171. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) | Trialion