Clinical Trial

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

Study acronym: HEM-iSMART D
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-12-13; most recent amendment 2025-09-09.
Status change: Not Yet Recruiting → Recruiting 2024-06-19
Trial Details
NCT Number NCT05658640
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: Innovative Therapies For Children with Cancer Consortium, IBFM, Fight Kids Cancer
Conditions Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Enrollment 26 participants
Start Date 2023-11-14
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-16