Overview

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

Status:
Not yet recruiting

Trial end date:
2029-04-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Princess Maxima Center for Pediatric Oncology

Collaborators:

Fight Kids Cancer
IBFM
Innovative Therapies For Children with Cancer Consortium

Treatments:

Cyclophosphamide
Cytarabine
Dexamethasone
Trametinib