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Anti-metabolites

Evorpacept + Azacitidine for Myelodysplastic Syndrome

Phase 1 & 2
Waitlist Available
Research Sponsored by ALX Oncology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase 2: Diagnosis of higher risk MDS that is previously untreated
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months
Awards & highlights

Study Summary

This trial will test a new drug, evorpacept, in combination with azacitidine to see if it can treat patients with higher risk myelodysplastic syndrome.

Who is the study for?
Adults over 18 with higher risk Myelodysplastic Syndrome (MDS) that is either untreated or has come back after treatment can join this study. They must have good kidney and liver function, and be physically able to participate. People who've had certain previous treatments or stem cell transplants, or active viral infections like hepatitis B/C, HIV/AIDS, or COVID-19 cannot take part.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Evorpacept (ALX148) and Azacitidine in patients with high-risk MDS. It's designed in two phases; the first phase includes those previously treated for MDS while the second focuses on those who haven't been treated before.See study design
What are the potential side effects?
Potential side effects from Evorpacept and Azacitidine may include reactions at the injection site, blood-related issues such as anemia or low platelets, gastrointestinal symptoms like nausea or constipation, fatigue, fever, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a high-risk type of MDS that hasn't been treated yet.
Select...
I am 18 years old or older.
Select...
I have a high-risk type of MDS that is either new or has come back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Dose Limiting Toxicities (DLT)
Phase 2: Complete response rate (CRR)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: evorpacept (ALX148) + azacitidineExperimental Treatment2 Interventions
Phase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
Group II: azacitidineActive Control1 Intervention
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
azacitidine
2005
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
1,275 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04417517 — Phase 1 & 2
Myelodysplastic Syndrome Research Study Groups: evorpacept (ALX148) + azacitidine, azacitidine
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04417517 — Phase 1 & 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417517 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research initiative still accepting participants?

"Per the information available on clinicaltrials.gov, this medical study is currently inviting participants to join; it was initially posted on October 2nd 2020 and refreshed for the last time on May 13th 2022."

Answered by AI

How widely available is this medical experiment in North America?

"At the moment, 8 medical institutions are participating in this trial. Establishments such as Fred Hutchinson Cancer Research Center of Seattle, University of Texas MD Anderson Cancer Centre from Houston and Mayo Clinic at Rochester can be found amongst the list alongside 5 additional sites."

Answered by AI

What is the estimated number of participants that will be recruited for this clinical trial?

"For the trial to take place, ALX Oncology Inc. must recruit 173 suitable participants from two renowned research centres - Fred Hutchinson Cancer Research Center in Seattle and University of Texas MD Anderson Cancer Centre in Houston."

Answered by AI

Are there additional experiments concerning evorpacept currently in progress?

"In 2006, the Chinese University of Hong Kong-Prince of Wales Hospital was the first to research evorpacept. There have been 160 studies completed and presently 174 clinical trials actively recruiting participants; notably a great number taking place in Seattle, Washington."

Answered by AI

What types of conditions are typically addressed with evorpacept?

"Evorpacept is the favoured treatment for malignant neoplasms, and can additionally be employed to address 20-30% blasts, neutropenia/thrombocytopenia, and anemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
2020. "A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417517.
~14 spots leftby Apr 2025
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