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NCT06456463 · ClinicalTrials.gov registry record · Phase 2
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Stemline Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT06456463: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by Stemline Therapeutics.
NCT06456463 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Stemline Therapeutics. The registered enrollment target is 83 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06456463, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Stemline Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT06456463 shows while recruiting
NCT06456463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (28% lower).
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.
NCT06456463 names 20 study sites across 11 states, led by New York, Massachusetts, California.
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.
What interventions are being tested in trial NCT06456463?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Tagraxofusp (DRUG).
Who is sponsoring clinical trial NCT06456463?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT06456463's enrollment target sits among peer trials
83 95th of 306 higher than 212 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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