Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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.

Official 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

Keywords

Acute Myeloid Leukemia, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Azacitidine, Venetoclax, Magrolimab, Magrolimab + Venetoclax + Azacitidine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 be considered ineligible for intensive chemotherapy, defined by the following:
    • ≥ 75 years of age; Or
    • ≥ 18 to 74 years of age with at least 1 of the following comorbidities:
      • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
      • Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65%
      • Left ventricular ejection fraction ≤ 50%
      • Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
      • Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN)
      • Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
    • ECOG performance status:
      • Of 0 to 2 for individuals ≥ 75 years of age Or
      • Of 0 to 3 for individuals ≥ 18 to 74 years of age
  • Individuals with white blood cell (WBC) count ≤ 20 x 103/μL prior to randomization. If the individual's WBC is > 20 x103/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 103/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.

    • Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to ≤ 20 x 103/μL to enable eligibility for study drug dosing
  • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment
    • Note: Transfusions are allowed to meet hemoglobin eligibility
  • Pretreatment blood cross-match completed

You CAN'T join if...

  • 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 (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea
      • Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals.
  • Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
  • Individuals who have acute promyelocytic leukemia
  • Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC Irvine Health- Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • Community Cancer Institute
    Fresno California 93730 United States
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05079230
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 432 study participants
Last Updated