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 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.

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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

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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