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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
NCT06456463 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Tagraxofusp
Study Locations (20)
New York
- Roswell Park Cancer Institute — Buffalo
- North Shore University Hospital — Manhasset
- NYU Langone Health — New York
- Columbia University Irving Medical Center — New York
Massachusetts
- Dana Farber Cancer Institute (DFCI) — Boston
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
California
- University of California, Los Angeles — Los Angeles
- Stanford Health Care — Stanford
Florida
- University of Miami — Miami
- AdventHealth Cancer Institute — Orlando
New Jersey
- John Theurer Cancer Center - Hackensack Meridian Health — Hackensack
- Rutgers Cancer Institute — New Brunswick
North Carolina
- Novant Health Presbyterian Medical Center — Charlotte
- Novant Health Derrick L Davis Cancer Center — Winston-Salem
Illinois
- University of Chicago — Chicago
Michigan
- Henry Ford Health System Brigitte Harris Cancer Pavillion — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2025-01-14 |
| Est. Completion | 2030-02-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06456463
The ClinicalTrials.gov registry entry for NCT06456463 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stemline Therapeutics, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06456463 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06456463 about?
NCT06456463 is a clinical study titled "A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy". 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 a...
What is the current status of trial NCT06456463?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2025-01-14. Estimated completion is 2030-02-11.
What conditions does trial NCT06456463 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06456463?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Tagraxofusp (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06456463?
This trial is sponsored by Stemline Therapeutics, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06456463 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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