NCT04755244

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

November 27, 2024

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

February 11, 2021

Last Update Submit

November 25, 2024

Conditions

Acute Myeloid LeukemiaAML, Adult

Keywords

ALX148CD47SIRPalphaazacitidinevenetoclaxevorpacept

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Dose Limiting Toxicities (DLT)

    Number of participants with a DLT

    Up to 28 days

  • Phase 2: Composite complete remission rate (CRc)

    Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria

    Approximately 6 months

Study Arms (1)

evorpacept (ALX148) + venetoclax + azacitidine

EXPERIMENTAL

Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine.

Drug: evorpaceptDrug: venetoclaxDrug: azacitidine

Interventions

evorpaceptDRUG

Fusion protein that blocks CD47-SIRPalpha pathway

Also known as: ALX148
evorpacept (ALX148) + venetoclax + azacitidine
venetoclaxDRUG

BCL-2 inhibitor

Also known as: Venclexta
evorpacept (ALX148) + venetoclax + azacitidine
azacitidineDRUG

Hypomethylating agent (HMA)

Also known as: Vidaza
evorpacept (ALX148) + venetoclax + azacitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.

    PMID: 36841672DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

ALX148venetoclaxAzacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

May 5, 2021

Primary Completion

May 5, 2023

Study Completion

August 16, 2023

Last Updated

November 27, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(5)