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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

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Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 confirmed centrally by flow cytometry.
  • 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 comorbidities:
      • 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 comorbidity that the investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor.
  • 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.
  • Willing and able to receive standard induction therapy.
  • Treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, chimeric antigen receptor-T therapy, or other experimental therapies.
  • AML with central nervous system involvement.

Note: Other inclusion/exclusion criteria may apply.

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Study Stats
Protocol No.
24-5352
Category
Leukemia
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06456463
For detailed technical eligibility, visit ClinicalTrials.gov.