drugset / Trial / NCT05740449
HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Phase 1/2
Withdrawn
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 A is a phase I/II trial evaluating the safety and efficacy of Decitabine / Venetoclax and Navitoclax in children and AYA with R/R pediatric ALL/LBL
Timeline
- Start
- 2023-10-01
- Primary completion
- 2029-10-01
- Completion
- 2029-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Navitoclax | Small molecule | — | Oral |
| Subject | Venetoclax | Small molecule | 200 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Prednisone | Other / unclassified | — | Intrathecal |