drugset / Trial / NCT05658640
HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies
Phase 1/2
Recruiting
26 enrolled
Princess Maxima Center for Pediatric Oncology
Fight Kids Cancer · collabIBFM · collabInnovative Therapies For Children with Cancer Consortium · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-11-14
- Primary completion
- 2029-04-01
- Completion
- 2029-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Trametinib | Small molecule | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Prednisone | Other / unclassified | — | Intrathecal |