A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Public ClinicalTrials.gov record NCT06456463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06456463
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2025 (Actual)
- Primary completion
- Feb 9, 2028 (Estimated)
- Completion
- Feb 11, 2030 (Estimated)
- Last update posted
- Aug 6, 2026
2025 – 2030
United States locations
- U.S. sites
- 24
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Stanford Health Care | Stanford | California | 94305 | — |
| University of Miami | Miami | Florida | 33136 | — |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Dana Farber Cancer Institute (DFCI) | Boston | Massachusetts | 02114 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System Brigitte Harris Cancer Pavillion | Detroit | Michigan | 48202 | — |
| Washington University - Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| John Theurer Cancer Center - Hackensack Meridian Health | Hackensack | New Jersey | 07601 | — |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Novant Health Derrick L Davis Cancer Center | Winston-Salem | North Carolina | 27103 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Sydney Kimmel (Thomas Jefferson University) | Philadelphia | Pennsylvania | 19107 | — |
| Sarah Cannon, the Cancer Institute of HCA Healthcare | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Baylor Scott & White Health | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06456463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06456463 live on ClinicalTrials.gov.