drugset / Trial / NCT06456463
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RandomizedSequentialOpen-labelTreatment
Summary
This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms/kilogram/day \[μg/kg/day\]), used in combination with venetoclax and azacitidine, to determine the dose for Part 2. This determined dose, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2 in 2 cohorts (TP53 mutated and TP53 wild type). Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.
Timeline
- Start
- 2025-01-14
- Primary completion
- 2028-02-09
- Completion
- 2030-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Tagraxofusp | Protein / enzyme biologic | 9 ug/kg | Intravenous |
| Subject | Tagraxofusp | Protein / enzyme biologic | 12 ug/kg | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |