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Anti-metabolites

Magrolimab for Myelodysplastic Syndrome (ENHANCE 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to 32.62 months

Awards & highlights

ENHANCE Trial Summary

This trial is testing a new drug, magrolimab, to see if it's more effective than azacitidine (a current standard of care drug) plus placebo in treating MDS. They will measure this by looking at complete remission and overall survival rates.

Eligible Conditions

Myelodysplastic Syndrome

ENHANCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to 32.62 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to 32.62 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to 32.62 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

Overall Survival (OS)

Percentage of Participants With Complete Remission (CR)

Secondary outcome measures

Duration of CR (DOCR)

Duration of Response (DOR)

Event Free Survival (EFS)

+10 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%

Tumour pain

11%

Hypertension

11%

Dyspnoea

11%

Dyspepsia

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%

Study treatment Arm

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Magrolimab 45 mg/kg

Magrolimab Priming Dose Only

ENHANCE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Magrolimab + AzacitidineExperimental Treatment2 Interventions

Participants will receive the following magrolimab and azacitidine dosing regimens: Magrolimab: Magrolimab Priming Dose: 1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50) Magrolimab Maintenance Dose: 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.

Group II: Control Arm (Placebo + Azacitidine)Placebo Group2 Interventions

Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Magrolimab

2021

Completed Phase 2

~170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,160 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,154 Total Patients Enrolled

Frequently Asked Questions

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

When might Magrolimab gain FDA approval for general use?

"Magrolimab is in a Phase 3 clinical trial, which means that there is some data to support its efficacy and multiple rounds of data to support its safety. Our team at Power estimates the safety of Magrolimab to be a 3 on a scale from 1 to 3."

Answered by AI

How many people are being helped by this lenalidomide study?

"This specific trial is not currently looking for more participants, as reflected by the date of the last edit. However, there are 1654 other trials involving patients with myelodysplastic syndromes and 190 studies for Magrolimab that are currently recruiting."

Answered by AI

Is this research being conducted exclusively in the United States?

"Currently, there are 51 sites across the globe enrolling patients for this study. A few notable locations include St. John's, Boston, and Columbus. If you are selected for the study, it is best to try and be placed at a site near to your residence to reduce travel burdens."

Answered by AI

How does Magrolimab compare to other drugs in its class?

"Magrolimab was first studied in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Since then, there have been a total of 18402 completed studies. As of now, there are 190 live trials, with a large concentration in St. John's, Ohio."

Answered by AI

What disorders does Magrolimab commonly alleviate?

"malignant neoplasms often respond well to Magrolimab, which is also indicated for treating 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

2020. "Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04313881.