Clinical trial · Interventional
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Tagraxofusp | Drug | Tagraxofusp | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1 - Tagraxofusp (9 μg/kg/day)
- description
- Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
- interventionNames
- Drug: Tagraxofusp
- Drug: Venetoclax
- Drug: Azacitidine
- type
- EXPERIMENTAL
- label
- Part 1 - Tagraxofusp (12 μg/kg/day)
- description
- Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
- interventionNames
- Drug: Tagraxofusp
- Drug: Venetoclax
- Drug: Azacitidine
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria:
* Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.
* Participant has any level of CD123 expression on blasts.
* Participants must be considered ineligible for intensive chemotherapy, defined by the following:
* ≥75 years of age; or
* ≥18 to 74 years of age with at least 1 of the following:
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
* Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%.
* Baseline creatinine clearance ≥30 to \<45 milliliters/minute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
* Hepatic disorder with total bilirubin \>1.5 x upper limit of normal.
* Any other condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.
* ECOG performance status:
* 0 to 2 for participants ≥75 years of age, or
* 0 to 3 for participants ≥18 to 74 years of age.
Key Exclusion Criteria:
* Participant has received prior therapy for AML.
* Participant is willing and able to receive standard induction therapy.
* 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.
* Participant has AML with central nervous system involvement.
Note: Other inclusion/exclusion criteria may apply.References
Publications (0)
Data not yet available