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Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia

NCT04778397•Gilead Sciences

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals with confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by either central laboratory or an approved local laboratory (after central review of the bone marrow TP53 mitigation next-generation sequencing test results) (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report).
•Individuals with white blood cell (WBC) count ≤ 20×10\^3/microliter (μL) prior to randomization. If the individual's WBC is \> 20×10\^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20×10\^3/μL prior to the first dose of study treatment and prior to each magrolimab dose the first 4 weeks (if the individual is randomized to the experimental arm) Note: Individuals can be treated with hydroxyurea and/or leukapheresis throughout the study or prior to randomization to reduce the WBC to ≤ 20×10\^3/μL to enable eligibility for study drug dosing.
•The hemoglobin must be ≥ 9 grams per deciliter (g/dL) prior to initial dose of study treatment.
•Notes: Transfusions are allowed to meet hemoglobin eligibility.
•Individual has provided informed consent.
•Individual is willing and able to comply with clinic visits and procedure outlined in the study protocol.
•Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, except for individuals less than 75 years of age and appropriate for non-intensive treatment. For these individuals, the ECOG performance status score may be 0 to 3.
•Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 milliliters per minute calculated by the Cockcroft Gault formula.
•Adequate cardiac function as demonstrated by:
•* Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease.
+8 more criteria

Exclusion Criteria

•Positive serum pregnancy test.
•Breastfeeding female.
•Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
•Prior treatment with any of the following:
•* Cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents
•* Antileukemic therapy for the treatment of AML (excluding hydroxyurea), hypomethylating agent (HMA), low dose cytarabine and/or venetoclax.
•Note: Individuals with prior myelodysplastic syndrome (MDS) who have not received prior HMAs or chemotherapeutic agents for MDS are allowed on study. Other prior MDS therapies including, but not limited to, lenalidomide, erythroid stimulating agents, or similar red blood cell (RBC)-direct therapies, were allowed. Localized non-central nervous system (CNS) radiotherapy, erythroid and/or myeloid growth factors, hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer, hormonal therapy or maintenance for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand inhibitors are also not criteria for exclusion.
•Individuals who are appropriate for intensive treatment but who have been previously treated with maximum cumulative doses of idarubicin and/or other anthracyclines and anthracenediones will be excluded.
•Individuals receiving any live vaccine within 4 weeks prior to initiation of study treatments.
•For individuals appropriate for intensive therapy, individuals treated with trastuzumab within 7 months prior to initiation of study treatments.
+15 more criteria

Locations (156)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

USC/ Norris Comprehensive Cancer Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UC Irvine Health

Orange, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Memorial Cancer Institute

Pembroke Pines, Florida, United States

Key Dates

Start Date

July 1, 2021

Primary Completion Date

March 25, 2024

Completion Date

March 25, 2024

Last Updated

February 5, 2025

Enrollment

258

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Magrolimab

DRUG

Venetoclax

DRUG

Azacitidine

DRUG

Cytarabine

DRUG

Daunorubicin

DRUG

Idarubicin

DRUG

Steroidal Eye Drops

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Inclusion Criteria

Exclusion Criteria

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