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 (Jun 2026). This Phase 2 trial studies multiple treatments including Tagraxofusp and Venetoclax for acute myeloid leukemia.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IL3RA any expression (any level)
any level of CD123 expression on blasts
Prior therapy
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 →Frequently asked questions
Is NCT06456463 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IL3RA?
Yes, IL3RA any expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages