Acute Myeloid Leukemia Clinical Trial

A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

Summary

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

97

Study ID:

NCT04755244

Recruitment Status:

Active, not recruiting

Sponsor:

ALX Oncology Inc.

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There are 5 Locations for this study

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Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

97

Study ID:

NCT04755244

Recruitment Status:

Active, not recruiting

Sponsor:


ALX Oncology Inc.

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