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Epigenetic Modifier

Magrolimab + Venetoclax + Azacitidine for Acute Myeloid Leukemia (ENHANCE-3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity
Individuals must have ECOG performance status of 0 to 2 for individuals ≥ 75 years of age or 0 to 3 for individuals ≥ 18 to 74 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

ENHANCE-3 Trial Summary

This trial will compare the effectiveness of two different treatment regimens for people with a certain type of leukemia who can't have intensive chemotherapy.

Who is the study for?
This trial is for adults with untreated acute myeloid leukemia (AML) who can't have standard chemotherapy due to age or health issues. They must be ineligible for intensive chemo, aged 18-74 with certain comorbidities or ≥75 years old, and have an ECOG performance status of up to 3 depending on age. Participants need a WBC count ≤20 x 10^3/μL and cannot have had prior treatments targeting CD47/SIRPα or AML-specific therapies.Check my eligibility
What is being tested?
The study compares magrolimab combined with venetoclax and azacitidine against a placebo combined with the same drugs in participants. The aim is to see if adding magrolimab improves outcomes for those unable to undergo standard chemotherapy due to their condition.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, fatigue, blood cell count changes leading to increased infection risk, bleeding or bruising easily, and possible organ function impairment.

ENHANCE-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have AML and can't receive standard treatment due to my age or health issues.
Select...
I am over 75 and can move around; or I am 18-74 and can at least partially care for myself.

ENHANCE-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Overall Survival (OS)
Secondary outcome measures
Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
Event-Free Survival (EFS)
+12 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782
67%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Myalgia
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypokalaemia
11%
Dyspepsia
11%
Tumour pain
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only

ENHANCE-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magrolimab + Venetoclax + AzacitidineExperimental Treatment3 Interventions
Participants will receive magrolimab: 1 mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses and every 2 weeks thereafter venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter azacitidine: 75 mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle Each cycle is 28 days.
Group II: Magrolimab Placebo + Venetoclax + AzacitidinePlacebo Group3 Interventions
Participants will receive magrolimab placebo: Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter azacitidine: 75 mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Magrolimab
2021
Completed Phase 2
~170
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,409 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,403 Total Patients Enrolled

Media Library

Azacitidine (Epigenetic Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT05079230 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Magrolimab Placebo + Venetoclax + Azacitidine, Magrolimab + Venetoclax + Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT05079230 — Phase 3
Azacitidine (Epigenetic Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05079230 — Phase 3

Frequently Asked Questions

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

What does the scientific community know about Magrolimab from past research?

"In 2006, researchers first studied magrolimab at Chinese University of Hong Kong-Prince of Wales Hospital. As of today, there have been a total of 213 completed clinical trials. There are currently 360 active ones with many taking place in Baltimore, Maryland."

Answered by AI

For what purpose is Magrolimab most often employed?

"Magrolimab is most often used as part of induction chemotherapy. Additionally, this medication can be prescribed to treat conditions like refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI

How many people are the doctors hoping to test this on?

"In order to begin the trial, 432 patients who meet specific requirements must enroll. Those interested in participating can do so at University of Maryland, Greenebaum Comprehensive Cancer Center in Baltimore, Maryland or Wake Forest Baptist Health in Winston-Salem, North carolina."

Answered by AI

Are there any vacancies in this particular clinical trial?

"Yes, this is an ongoing study that has been advertised on clinicaltrials.gov since July 7th, 2020. The trial requires 432 patients to be enrolled at seven different medical facilities."

Answered by AI

How has Magrolimab been received by the FDA?

"Magrolimab's safety is supported by both efficacy data and multiple rounds of research, so it received a score of 3."

Answered by AI

Are there many places in town where this experiment is taking place?

"At the moment, there are 7 sites where you can enroll in this study. They are situated in Baltimore, Winston-Salem and Fort Sam Houston as well as 4 other locations. If you want to cut down on travel time, then it would be best to select a location near you."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
2022. "Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05079230.
~173 spots leftby Jul 2025
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