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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

Must not have

Individuals who have acute promyelocytic leukemia

Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML and can't receive standard treatment due to my age or health issues.

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I am over 75 and can move around; or I am 18-74 and can at least partially care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with acute promyelocytic leukemia.

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I have not been treated with CD47 or SIRPα-targeting agents before.

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I have received treatment for AML, but not including hydroxyurea.

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My leukemia is suspected to or has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

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)

+8 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Abdominal pain

33%

Infusion related reaction

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Malignant neoplasm progression

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

33%

Lactic acidosis

33%

Nausea

33%

Aspartate aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Blood lactate dehydrogenase increased

33%

Mental disorder

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab Priming Dose Only

Magrolimab 45 mg/kg

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2240

Magrolimab

2022

Completed Phase 2

~220