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Enzyme

ADI-PEG 20 + Venetoclax + Azacitidine for Acute Myeloid Leukemia

Phase 1
Recruiting
Research Sponsored by Polaris Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lead In and Cohort 1: Previously treated AML based on the revised 2017 European LeukemiaNet (ELN) criteria and having ≥10% blasts in bone marrow or peripheral blood; Age ≥18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study the addition of ADI-PEG 20 to venetoclax and azacitidine in patients with high-risk AML.

Who is the study for?
This trial is for adults with high-risk Acute Myeloid Leukemia (AML). It's specifically for those aged 65 or older who can't have intensive chemotherapy due to age, heart disease, previous treatments, or risk of treatment-related death. Participants need a reasonable life expectancy and controlled white blood cell count. They must also have adequate kidney and liver function but cannot join if they've had certain prior AML treatments or have leukemia in the brain/spinal cord.Check my eligibility
What is being tested?
The study tests ADI-PEG 20 combined with venetoclax and azacitidine in patients with AML. Venetoclax and azacitidine are standard first-line therapies; this trial adds ADI-PEG 20 to see if it improves outcomes. The study has two parts: one for previously treated patients (Phase IA) and another for untreated elderly patients at high risk (Phase IB).See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever or chills, digestive issues like nausea or constipation, potential impact on blood cells leading to increased infection risk or bleeding problems, fatigue, liver function changes, and kidney-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have AML with more than 10% blasts in my blood or bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the RP2D of ADI-PEG 20 in combination with venetoclax and azacitidine, per the number of subjects with treatment-related adverse events by current CTCAE
Secondary outcome measures
Determine preliminary evidence of tumor activity, per the revised 2017 European LeukemiaNet criteria
Determine the anti-drug antibodies of ADI-PEG 20 in combination with venetoclax and azacitidine
Determine the peripheral blood arginine levels of ADI-PEG 20 in combination with venetoclax and azacitidine
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Untreated AML With High Risk FeaturesExperimental Treatment1 Intervention
Untreated AML per ELN criteria with high risk features, or age ≥ 65 years and ineligible for intensive chemotherapy because of older than 75 years, cardiac disease or prior anthracycline use or high probability of treatment-related mortality
Group II: Previously Treated AMLExperimental Treatment1 Intervention
Previously treated AML based on the revised 2017 European LeukemiaNet (ELN) criteria with age at least 18 years, and having ≥10% blasts in bone marrow or peripheral blood
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADI-PEG 20
2013
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Polaris GroupLead Sponsor
24 Previous Clinical Trials
3,227 Total Patients Enrolled
John S BomalaskiStudy DirectorPolaris Group
3 Previous Clinical Trials
640 Total Patients Enrolled

Media Library

ADI-PEG 20 (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT05001828 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Previously Treated AML, Untreated AML With High Risk Features
Acute Myeloid Leukemia Clinical Trial 2023: ADI-PEG 20 Highlights & Side Effects. Trial Name: NCT05001828 — Phase 1
ADI-PEG 20 (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05001828 — Phase 1

Frequently Asked Questions

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

What has been the traditional application of ADI-PEG 20?

"ADI-PEG 20 is a medicine used to treat induction chemotherapy and certain forms of anemias, leukemia, myelocytic, acute, as well as multilineage dysplasias."

Answered by AI

What other research has been done to evaluate ADI-PEG 20?

"Presently, 342 trials for ADI-PEG 20 are ongoing. 54 of these studies are currently in their final phase prior to approval. Most tests conducted with this medication occur in Edmonton, Alberta; however, 11194 other medical centres across the world have implemented clinical trials involving ADI-PEG 20."

Answered by AI

What is the uppermost patient cap for this clinical trial?

"Affirmative. This clinical trial, initially posted on April 5th 2022, is currently in need of participants and the information can be found online at clinicaltrials.gov. 60 people are being sought from one medical facility to take part in this research project."

Answered by AI

Are individuals aged 55 and above eligible for participation in this research?

"The requirements for enrollment in this clinical research stipulate that prospects must fall within the 18-99 age range. There are 466 trials available to individuals younger than 18 and 1,500 offered to those aged 65 or older."

Answered by AI

What detrimental effects can ADI-PEG 20 have on those undergoing treatment?

"With limited data available to evaluate its efficacy and safety, ADI-PEG 20 was assigned a score of 1 on our team's scale."

Answered by AI

Are any fresh participants being recruited for this investigation?

"Affirmative. According to the information posted online, this clinical trial is actively looking for participants. It was first advertised on April 5th 2022 and its most recent update came out on September 29th 2022. The research team requires 60 volunteers at one medical centre."

Answered by AI

Who has the opportunity to join this medical trial?

"This clinical trial is seeking 60 individuals with leukemia, aged between 18-99 years old. In order to qualify for enrollment, the patient must meet certain criteria; such as having untreated AML per ELN standards and high risk features, a white blood cell count of 10x10^9/L or below (use of hydroxyurea accepted up to 48 hours prior), previously treated AML based on revised 2017 European LeukemiaNet (ELN) criteria coupled with ≥10% blasts in bone marrow/peripheral blood, life expectancy deemed adequate for evaluating treatment response, creatinine ≤ 1.5 x upper limit of"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia
2022. "Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05001828.
~22 spots leftby Jul 2025
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