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New targeted therapy aims to beat back childhood leukemia relapse

NCT ID NCT05748171

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests a drug called inotuzumab ozogamicin (Besponsa) against standard chemotherapy for children aged 1 to 17 with high-risk B-cell acute lymphoblastic leukemia that has returned after initial treatment. The goal is to see if the targeted drug can clear more cancer cells from the bone marrow after one cycle of therapy. About 100 children will take part, and researchers will monitor their health and cancer status for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inotuzumab ozogamicin (Besponsa)
What this could lead to
If successful, this could offer a more effective, less toxic first treatment for children whose leukemia has returned, potentially leading to better remission rates and fewer side effects.
What could go wrong
This is a Phase 2 trial with only 100 participants, so results are preliminary. The drug may not prove superior to standard chemo, and side effects like liver toxicity or infections are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia leukemia precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    66 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Paris, Paris, 75935, France

  • Astrid Lindgrens Barnsjukhus

    RECRUITING

    Stockholm, 17067, Sweden

  • Azienda Ospedale - Università Padova

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon

    RECRUITING

    Naples, Campania, 80123, Italy

  • Bordeaux University Hospital - Pellegrin

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • CHRU De Rennes - Hôpital Sud

    RECRUITING

    Rennes, 35203, France

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

    RECRUITING

    Strasbourg, Alsace, 67000, France

  • CHU de Nantes - Hôpital Mère - Enfants

    RECRUITING

    Nantes, 44000, France

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

    RECRUITING

    Toulouse, Haute-garonne, 31059, France

  • CHUS - Hospital Clinico Universitario

    RECRUITING

    Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

  • CHUS - Hospital Clinico Universitario

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • CHUV (centre hospitalier universitaire vaudois)

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, Meurthe-et-moselle, 54511, France

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    RECRUITING

    Nice, Alpes-maritimes, 06202, France

  • Charité Campus Virchow-Klinikum

    RECRUITING

    Berlin, 13353, Germany

  • Cliniques universitaires Saint-Luc

    RECRUITING

    Brussels, Bruxelles-capitale, Région de, 1200, Belgium

  • Detska nemocnice FN Brno

    RECRUITING

    Brno, Brno-město, 613 00, Czechia

  • Fakultni Nemocnice Motol a Homolka

    RECRUITING

    Prague, 150 00, Czechia

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Lombardy, 20900, Italy

  • Helsinki university hospital

    RECRUITING

    Helsinki, 00290, Finland

  • Hospital Clinico Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Infantil Universitario Niño Jesús

    RECRUITING

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Sant Joan de Déu

    RECRUITING

    Esplugues de Llobregat, Barcelona [barcelona], 08950, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hôpital Armand Trousseau

    RECRUITING

    Paris, 75571, France

  • Hôpital Jeanne de Flandre - CHRU

    RECRUITING

    Lille, NORD, 59037, France

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genoa, Liguria, 16147, Italy

  • IRCCS Materno Infantile Burlo Garofolo

    RECRUITING

    Trieste, 34137, Italy

  • Inselspital Bern

    RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • Institut d'Hématologie et d'Oncologie Pédiatrique

    RECRUITING

    Lyon, 69008, France

  • Kinderspital Zürich

    RECRUITING

    Zurich, 8008, Switzerland

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Narodny ustav detskych chorob

    RECRUITING

    Bratislava, Bratislava Region, 833 40, Slovakia

  • Oslo Universitetssykehus Rikshospitalet

    RECRUITING

    Oslo, 0372, Norway

  • Ospedale Pediatrico Bambino Gesù IRCCS

    RECRUITING

    Rome, ROMA, 00165, Italy

  • Ospedale Regina Margherita

    RECRUITING

    Torino, 10126, Italy

  • Policlinico "G. Rodolico"

    RECRUITING

    Catania, Sicily, 95123, Italy

  • Prinses Maxima Centrum voor Kinderoncologie

    RECRUITING

    Utrecht, 3584 CS, Netherlands

  • Radium Hospital

    RECRUITING

    Oslo, 0379, Norway

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Northern District, 3109601, Israel

  • Rigshospitalet

    RECRUITING

    Copenhagen, Capital Region, DK-2100, Denmark

  • Sahlgrenska Universitetssjukhuset Östra

    RECRUITING

    Gothenburg, Västra Götalands LÄN [se-14], 416 85, Sweden

  • Schneider Children's Medical Center

    RECRUITING

    Petah Tikva, Central District, 49202, Israel

  • Skånes Universitetssjukhus Lund

    RECRUITING

    Lund, Skåne LÄN [se-12], 22185, Sweden

  • St. Anna Kinderspital

    RECRUITING

    Vienna, 1090, Austria

  • Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

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

    RECRUITING

    Tel Aviv, TELL ABĪB, 6423906, Israel

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

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • UZ Gent

    RECRUITING

    Ghent, Oost-vlaanderen, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-brabant, 3000, Belgium

  • Universitaetsklinikum Duesseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitaetsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitätsklinikum Frankfurt Goethe-Universität

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsklinikum Gießen

    RECRUITING

    Giessen, 35392, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

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