Clinical Trial

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Study acronym: TRILLIUM
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Enrollment closed, study ongoing 2026-08-07
Trial Details
NCT Number NCT06456463
Lead Sponsor Stemline Therapeutics, Inc.
Conditions Acute Myeloid Leukemia
Enrollment 85 participants
Start Date 2025-01-14
Primary Completion 2028-02-09 (estimated)
Study Completion 2030-02-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-06