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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
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Enrollment target: estimated 83 to confirmed 85
    • Site details revised at 32 of 32 sites
    v19
  2. Study sites: 33 to 32v18
  3. Enrollment target: 76 to 83
    • Secondary endpoints: 18 to 19
    • Site details revised at 1 of 33 sites
    v17
  4. Study sites revised (33)v16
  5. Study sites revised (33)v15
Show 13 earlier versionsHide 13 earlier versions
  1. Secondary endpoints: 13 to 18
    • Site details revised at 2 of 33 sites
    • Eligibility criteria shortened, about 2 words
    v14
  2. Study sites revised (33)v13
  3. Study sites: 32 to 33v12
  4. Study sites: 30 to 32v11
  5. Site details revised at 4 of 30 sitesv10
  6. Study sites: 36 to 30v9
  7. Eligibility criteria shortened, about 17 words
    • Site details revised at 4 of 36 sites
    v8
  8. Re-verified, no change to tracked fieldsv7
  9. Start date changed from estimate of Dec 2024 to Jan 14, 2025v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 35 to 36
    • Start date: Nov 30, 2024 to Dec 2024
    v5
  11. Study sites: 34 to 35v4
  12. Start date: Aug 30, 2024 to Nov 30, 2024
    • Primary endpoints: 1 to 2
    • Study sites: 18 to 34
    • Study arms: 3 to 4
    v3
  13. Study sites: 9 to 18
    • Eligibility criteria expanded, about 54 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06456463
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov