ENHANCE-3
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
IRAS ID
1004331
Contact name
Evelyn Rustia
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2021-003434-36
Clinicaltrials.gov Identifier
Research summary
Gilead Sciences, Inc is sponsoring a clinical research study to test an experimental medication named magrolimab in combination with other medications for the treatment of acute myeloid leukaemia (AML). The purpose of this study is to see if magrolimab in combination with venetoclax and azacitidine is more effective than venetoclax and azacitidine in participants newly diagnosed with AML that are unfit for intensive chemotherapy.
The study will enrol approximately 432 participants at about 170 locations globally. Taking part in this study will last about 9 months or longer, not including the screening visit. Active participation in the study, including treatment with the study medications, may continue as long as the participant is tolerating the study treatment, their cancer has not progressed, they do not start a new AML treatment, or the study is not stopped.
Study schedule:
• Screening period (3-8 hours)
• Treatment period
• End of treatment visit
• Safety follow-up visit/call (30 and 70 days from last dose of study medication)
• Long-term follow-up (every 12 weeks until starting new AML treatment)
• Survival Follow-up (every 2 months)Study assessments include: physical examinations, vital signs, collecting blood, urine, bone marrow aspirate and/or biopsy, electrocardiogram, echocardiogram or Multiple-gated acquisition scans, pulmonary (lung) function test, buccal (cheek) swab, completion of health related quality of life and physical function questionnaires.
Lay summary of study results
Following an independent data monitoring committee (iDMC) meeting to analyse overall survival (OS), Gilead decided to terminate the ENHANCE-3 study on 05-Feb-2024, based on the determination of futility. This means the Magrolimab treatment group had increased rates of several adverse events, including anaemia and hyperbilirubinanaemia, leading to death. Haemoglobin levels in the treatment group during Cycle 1 dropped to a greater degree than in the placebo group and did not completely recover to the same level as the placebo group. The combination of magrolimab with venetoclax and azacitidine is not expected to lead to a survival benefit compared to venetoclax and azacitidine in the study indication. The US FDA placed all magrolimab studies in MDS and AML on full clinical hold.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0159
Date of REC Opinion
22 Jun 2022
REC opinion
Further Information Favourable Opinion