A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Launched by STEMLINE THERAPEUTICS, INC. · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with a type of blood cancer called acute myeloid leukemia (AML) who cannot undergo standard intensive chemotherapy. The treatment being tested combines three medications: tagraxofusp, venetoclax, and azacitidine. The study is divided into two parts. In the first part, researchers will test two different doses of tagraxofusp to find the best dose to use in the second part, which will look specifically at how well the combination works for patients with different genetic profiles (TP53 mutated and TP53 wild type).

To be eligible for this trial, participants must have a confirmed diagnosis of CD123+ AML and be unable to receive standard chemotherapy due to age or other health issues. This includes individuals aged 75 or older, or those between 18 and 74 with specific health conditions that would make intensive treatment unsafe. Participants can expect regular check-ups and monitoring throughout the trial to assess how well the treatment is working and to manage any side effects. This study offers a potential new treatment option for those who currently have limited choices due to their health status.

Gender

ALL

Eligibility criteria

• 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.