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New targeted therapy aims to beat back childhood leukemia relapse

NCT ID NCT05748171

Recruiting now Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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 Arnaud de Villeneuve - CHU Montpellier

    RECRUITING

    Montpellier, Hérault, 34090, France

  • Hôpital Jeanne de Flandre - CHRU

    RECRUITING

    Lille, NORD, 59037, France

  • IRCCS - AOU di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • 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

  • Medanta - The Medicity

    NOT_YET_RECRUITING

    Gurugram, Haryana, 122001, India

  • 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

  • Pécsi Tudományegyetem Klinikai Központ

    RECRUITING

    Pécs, Baranya, 7623, Hungary

  • Radium Hospital

    RECRUITING

    Oslo, 0379, Norway

  • Rajiv Gandhi Cancer Institute and Research Centre

    NOT_YET_RECRUITING

    Delhi, 110085, India

  • 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

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1094, Hungary

  • 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

    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 Tuebingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, 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