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OncoMatch/Clinical Trials/NCT06456463

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

Is NCT06456463 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tagraxofusp and Venetoclax for acute myeloid leukemia.

Phase 2RecruitingStemline Therapeutics, Inc.NCT06456463Data as of May 2026

Treatment: Tagraxofusp · Venetoclax · Azacitidine — 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: IL3RA any expression (any level)

any level of CD123 expression on blasts

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any therapy for AML

Participant has received prior therapy for AML

Cannot have received: therapy for antecedent hematologic disease (hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, other experimental therapies)

Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, or other experimental therapies

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, Los Angeles · Los Angeles, California
  • Stanford Health Care · Stanford, California
  • University of Miami · Miami, Florida
  • AdventHealth Cancer Institute · Orlando, Florida
  • University of Chicago · Chicago, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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