Status:
TERMINATED
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
Lead Sponsor:
ALX Oncology Inc.
Conditions:
Acute Myeloid Leukemia
AML, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04755244
Start Date
May 5 2021
End Date
August 16 2023
Last Update
November 27 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203