Acute Myeloid Leukemia Clinical Trial
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML.
Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification.
Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy.
Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen.
Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy.
Adequate renal and liver function.
Age ≥18 years.
Adequate performance status.
In Phase 1a and 1b, patients that have undergone prior allo-HSCT must be at least 3 months post-HSCT, without uncontrolled graft-versus-host disease (GVHD). For Phase 2, patients that have undergone prior allo-HSCT are excluded.
Patients with newly diagnosed AML with favorable risk cytogenetics such as t(8;21), inv(16), or t(16;16) as per the NCCN Guidelines Version 3, 2019 for AML.
Patients with acute promyelocytic leukemia (APL).
Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent.
Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
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There are 5 Locations for this study
Chicago Illinois, 60611, United States
Buffalo New York, 14263, United States
Durham North Carolina, 27710, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
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