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Study identifier: NCT05658640 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies

Condition: Acute Lymphoblastic Leukemia, in Relapse · Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent · Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent  ·  Sponsor: Princess Maxima Center for Pediatric Oncology

PhasePhase 1/Phase 2
Planned participants26
Who can joinAll sexes, 1 Year to 21 Years
Healthy volunteersNo

About this study

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol D is a phase I/II trial evaluating the safety and efficacy of trametinib in combination with dexamethasone, cyclophosphamide and cytarabine in children and AYA with R/R ped ALL/LBL whose tumor present with alterations in the RAS-RAF-MAPK pathway.

This description comes directly from the study's public registry record.

Talk to the study team

Anne Elsinghorst  ·  +316 5000 6270  ·  hem-ismart@prinsesmaximacentrum.nl

Always discuss trial participation with your own doctor first.

Locations (36)

St. Anna KinderspitalVienna, AustriaNot Yet Recruiting
Universitair Ziekenhuis GentGhent, BelgiumNot Yet Recruiting
Rigshospitalet CopenhagenCopenhagen, DenmarkRecruiting
Helsinki University Hospital, New Children's HospitalHelsinki, FinlandNot Yet Recruiting
Hôpital des Enfants GH Pellegrin - CHU de BordeauxBordeaux, FranceNot Yet Recruiting
CHRU Lille - Hôpital Jeanne de FlandreLille, FranceNot Yet Recruiting
Centre Léon BérardLyon, FranceNot Yet Recruiting
Hopital La Timone - EnfantsMarseille, FranceNot Yet Recruiting
CHU Nantes Hôpital Mère-EnfantNantes, FranceNot Yet Recruiting
Hôpital Robert DebréParis, FranceNot Yet Recruiting
Universitätsklinikum AugsburgAugsburg, GermanyNot Yet Recruiting
Charité Universitätsmedizin BerlinBerlin, GermanyRecruiting

+ 24 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05658640