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PSCI 21-176 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

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.

Participants will be required to provide medical history, complete physical exam, laboratory tests, bone marrow biopsy and aspirate, ECOG, ECG, Echo or MUGA, pulmonary function tests, questionnaires, take study drug


Shin Mineishi
PSCI-CTO at or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Previously untreated patients with histological confirmation of AML by WHO criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.
ECOG performance status: a) Of 0 to 2 for subjects ≥ 75 years of age Or b) Of 0 to 3 for subjects ≥ 18 to 74 years of age
Patients with white blood cell (WBC) count ≤ 20  103/μL prior to randomization.
Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment.
Patient has provided informed consent

Exclusion Criteria:
Positive serum pregnancy test
Breastfeeding female
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
Patients receiving any live virus vaccine within 4 weeks prior to initiation of study treatments
Prior treatment with any of the following: a) CD47 or SIRPα-targeting agents
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,