New combo therapy offers hope for kids with tough leukemia

NCT ID NCT05658640

Recruiting now Disease control Sponsor: Princess Maxima Center for Pediatric Oncology Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new combination of drugs for children and young adults whose leukemia or lymphoma has returned or not responded to treatment. The drugs include trametinib (a targeted therapy) plus standard chemotherapy. The goal is to find the safest dose and see if the combination can shrink tumors or clear cancer cells from the bone marrow. About 26 participants will be enrolled.

What this could mean

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

Active substance: Trametinib (a targeted cancer drug) combined with dexamethasone, cyclophosphamide, and cytarabine (chemotherapy drugs)
What this could lead to: If successful, this could offer a new treatment option for children with hard-to-treat leukemia or lymphoma that has come back or not responded to standard therapy.
What could go wrong: This is an early-phase trial with only 26 participants, so results may not apply to all patients. The drug combination may cause side effects or not work better than existing treatments.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia leukemia Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma precursor lymphoblastic lymphoma/leukemia Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Recurrence refractory precursor T-lymphoblastic lymphoma/leukemia

As listed by the trial registrant

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

ACUTE LYMPHOBLASTIC LEUKEMIA, IN RELAPSE LYMPHOBLASTIC LYMPHOMA (PRECURSOR B-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA) RECURRENT LYMPHOBLASTIC LYMPHOMA (PRECURSOR B-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA) REFRACTORY LYMPHOBLASTIC LYMPHOMA (PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA) RECURRENT LYMPHOBLASTIC LYMPHOMA (PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA) REFRACTORY

Contacts and locations

Locations

Bristol Royal Hospital for Children
NOT_YET_RECRUITING

Bristol, B52 8BJ, United Kingdom
CHRU Lille - Hôpital Jeanne de Flandre
NOT_YET_RECRUITING

Lille, 59037, France
CHU Nantes Hôpital Mère-Enfant
NOT_YET_RECRUITING

Nantes, 44093, France
Centre Léon Bérard
NOT_YET_RECRUITING

Lyon, 69 373, France
Charité Universitätsmedizin Berlin
RECRUITING

Berlin, 13353, Germany
Fondazione MBBM c/o Centro ML Verga
NOT_YET_RECRUITING

Monza, 20900, Italy
Great North Children's Hospital
NOT_YET_RECRUITING

Newcastle, NE1 4LP, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
NOT_YET_RECRUITING

London, WC1N 2BH, United Kingdom
Helsinki University Hospital, New Children's Hospital
NOT_YET_RECRUITING

Helsinki, FI00029, Finland
Hopital La Timone - Enfants
NOT_YET_RECRUITING

Marseille, 13005, France
Hospital Infantil Universitario Niño Jesús
NOT_YET_RECRUITING

Madrid, 28009, Spain
Hospital Sant Joan de Déu de Barcelona
NOT_YET_RECRUITING

Barcelona, 08950, Spain
Hospital Vall d'Hebron
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Hôpital Robert Debré
NOT_YET_RECRUITING

Paris, 75019, France
Hôpital des Enfants GH Pellegrin - CHU de Bordeaux
NOT_YET_RECRUITING

Bordeaux, 33076, France
IRCCS Istituto Giannina Gaslini
NOT_YET_RECRUITING

Genova, 16147, Italy
Karolinska university hospital
RECRUITING

Stockholm, 171 76, Sweden
La Fe
NOT_YET_RECRUITING

Valencia, 46026, Spain
Oslo University Hospital
RECRUITING

Oslo, 0373, Norway
Ospedale Infantile Regina Margherita
NOT_YET_RECRUITING

Turin, 10126, Italy
Ospedale Pediatrico Bambino Gesù, IRCCS
NOT_YET_RECRUITING

Roma, 0165, Italy
Our Lady's Hospital for Sick Children
NOT_YET_RECRUITING

Dublin, D12N512, Ireland
Padova Azienda Ospedaliera
NOT_YET_RECRUITING

Padova, 35128, Italy
Princess Máxima Center for Pediatric Oncology
RECRUITING

Utrecht, Utrecht, 3584CS, Netherlands
Rigshospitalet Copenhagen
RECRUITING

Copenhagen, DK-2100, Denmark
Royal Manchester Children's Hospital
NOT_YET_RECRUITING

Manchester, M13 9WL, United Kingdom
Royal Marsden NHS Trust
NOT_YET_RECRUITING

Sutton, SM2 5PT, United Kingdom
Schneider's Children's Medical Center
NOT_YET_RECRUITING

Petah Tikva, 4920235, Israel
Sheba Medical Center Hospital
NOT_YET_RECRUITING

Ramat Gan, 52621, Israel
St. Anna Kinderspital
NOT_YET_RECRUITING

Vienna, 1090, Austria
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING

Ghent, 9000, Belgium
University Children's Hospital Zürich
NOT_YET_RECRUITING

Zurich, CH-8032, Switzerland
Universitätsklinikum Augsburg
NOT_YET_RECRUITING

Augsburg, 86156, Germany
Universitätsklinikum Essen
NOT_YET_RECRUITING

Essen, 45147, Germany
Universitätsklinikum Frankfurt
NOT_YET_RECRUITING

Frankfurt, 60590, Germany
Universitätsklinikum Münster
NOT_YET_RECRUITING

Münster, 48149, Germany

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