Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
HP Version - Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
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Closed (no longer recruiting)Last updated: 7 February 2024
Clinical summaryEligibilityParticipating hospitalsSupport
Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza) : Participants with newly diagnosed untreated AML who are ineligible for intensive induction chemotherapy will receive magrolimab, venetoclax and azacitidine. THIS COHORT IS CLOSED FOR ENROLLMENT UNTIL FURTHER NOTICE. Biological: Magrolimab : Administered intravenously This study consists of 3 safety run-in cohorts;Safety Run-in Cohort 1 (1L Unfit AML Mag + Ven + Aza)Safety Run-in Cohort 2 (R/R AML Mag + MEC)Safety Run-in Cohort 3 (Post-chemo Maintenance Mag + CC-486)Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts, after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor. After completion of each safety run-in cohort and identification of the RP2D for that cohort, participants will be enrolled into the corresponding Phase 2 cohorts;Phase 2 Cohort 1 (1L Unfit UML Mag + Ven + Aza)Phase 2 Cohort 2 (R/R AML Mag + MEC)Phase 2 Cohort 3 (Post-chemo Maintenance Mag + CC-486)Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.
This trial is treating patients with Acute Myeloid Leukaemia.
Haematological
18+
II
GS-US-546-5920
Use the hyperlinks, where available to access additional clinical trial information.
Gilead Sciences, Inc.
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Myeloid Malignancies
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All Individuals:
Safety Run-in Cohort 1 and Phase 2 Cohort 1 [Ineligible (1L) Unfit AML Mag+Ven+Aza)]:
Newly diagnosed, previously untreated individuals with histological confirmation of AML by world health organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, comorbidity, or other factors. Individuals must be considered ineligible for induction therapy defined by the following:
≥ 18 to 74 years of age with at least 1 of the following comorbidities:
Safety Run-in Cohort 2 and Phase 2 Cohort 2 [Relapsed/refractory (R/R) AML Mag+MEC)]:
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maintenance Mag+CC-486):
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 anti-cancer therapies and have had no evidence of active malignancy for over 1 year. Previous hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trials have complex eligibility criteria.
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