drugset / Trial / NCT07175415
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Phase 1/2
Not yet recruiting
42 enrolled
Princess Maxima Center for Pediatric Oncology
AbbVie · collabAstraZeneca · 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 E is a phase I/II trial evaluating the safety and efficacy of capivasertib + venetocolax in combination with dexamethasone in children and AYA with R/R ped ALL/LBL whose tumor present with alterations of the PAM pathway, or lacking any mutations.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2031-10-01
- Completion
- 2032-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capivasertib | Small molecule | — | Oral |
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Prednisone | Other / unclassified | — | Intrathecal |