Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Gilead Sciences
Study ID
NCT05079230
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magrolimab — DRUG
    Administered intravenously (IV)
  • Venetoclax — DRUG
    Tablets administered orally
  • Azacitidine — DRUG
    Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)
  • Placebo — DRUG
    Administered intravenously (IV)

Study Details

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

Key Dates

Start date
Jul 7, 2022
Status verified
Apr 2025
Primary completion
Apr 11, 2024
Completion
Apr 11, 2024

Study Design

Enrollment
378 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Magrolimab + Venetoclax + Azacitidine
    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.
  • Placebo Comparator: Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Participants will receive * magrolimab matching 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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 1.6 years ]

Locations (39)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
Community Cancer InstituteFresnoCalifornia93730-
UC Irvine Health- Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
Moffitt Cancer CenterTampaFlorida33612-
Loyola University Medical CenterMaywoodIllinois60153-
Parkview Research CenterFort WayneIndiana46845-
Indiana Blood and Marrow Transplantation - ClinicIndianapolisIndiana46237-
The University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
University of Massachusetts WorcesterWorcesterMassachusetts01655-
MidAmerica Division, Inc., c/o Research Medical CenterKansas CityMissouri64132-
SSM Health Saint Louis University HospitalSt LouisMissouri63110-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount Sinai and The Mount Sinai HospitalNew YorkNew York10029-
New York-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
UNC Hospitals, The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Novant Health Cancer Institute Hematology- CharlotteCharlotteNorth Carolina28204-
Novant Health Cancer Institute Hematology - ForsythWinston-SalemNorth Carolina27103-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27103-
Cleveland Clinic FoundationClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Providence Cancer Institute Franz ClinicPortlandOregon97213-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
West Penn HospitalPittsburghPennsylvania15224-
Rhode Island HospitalProvidenceRhode Island02903-
Baylor University Medical CenterDallasTexas75246-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
Houston Methodist Hospital Cancer CenterHoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030-
Intermountain Health - LDS HospitalSalt Lake CityUtah84143-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Virginia Mason Franciscan HealthSeattleWashington98101-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Little Rock, AR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Arkansas for Medical Sciences· Little Rock, ARCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CACommunity Cancer Institute· Fresno, CAUC Irvine Health- Chao Family Comprehensive Cancer Center· Orange, CABaptist MD Anderson Cancer Center· Jacksonville, FLMoffitt Cancer Center· Tampa, FL

Related Studies