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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
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06456463.
