drugset / Trial / NCT05955261
A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: \- Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy
Timeline
- Start
- 2023-07-25
- Primary completion
- 2026-12
- Completion
- 2034-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Azacitidine | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Gemtuzumab Ozogamicin | Monoclonal antibody | — | Intravenous |
| Background | Gilteritinib | Small molecule | — | Oral |
| Background | Idarubicin | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | — | Intravenous |