Submission: State Society or Hem Onc Group webpage – Tagraxofusp AML 0423 clinical trial MED-05227 12/2024
- December 27, 2024
- Clinical Trials
A Phase 2 Study of Tagraxofusp in Combination with Venetoclax and Azacitidine in Adults with Untreated CD123+ Acute Myeloid Leukemia (AML) Who Cannot Undergo Intensive Chemotherapy
This multicenter open-label phase 2 study will evaluate Tagraxofusp (TAG) in combination with Venetoclax and Azacitidine (Ven/Aza) in adults with previously untreated CD123+ AML who are ineligible for intensive chemotherapy. Part 1 will evaluate 2 dose levels of tagraxofusp (9 and 12 μg/kg/day) to determine the recommended dose for part 2. Part 2 will include 2 cohorts of patients (TP53 mutated and TP53 wild type) with a primary endpoint of best overall response of complete remission within the first 4 cycles of treatment. All patients enrolled on the study will receive the combination of TAG with standard of care Ven/ Aza. The study aims to enroll 72 patients across sites in the United States, Australia, and South Korea.
