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

Clinical Trial Details

This clinical trial is for men and women with newly diagnosed Acute Myeloid Lymphoma (AML) who are not eligible for intensive chemotherapy.

The purpose of this study is to evaluate the safety and effectiveness of the addition of an experimental drug, magrolimab, in combination with venetoclax and azacitidine compared to venetoclax and azacitidine alone.

Experimental means that magrolimab has not yet been approved by the U.S. Food and Drug Administration (FDA).

Venetoclax and Azacitidine are approved by the FDA, however, they have not been approved for use in combination with magrolimab. Therefore, they are considered investigational in this study.

Participants will be randomized to receive either magrolimab in combination with venetoclax and azacitidine, or a placebo with venetoclax and azacitidine. The placebo will look like magrolimab, but it contains no active drug. There is an equal chance of being assigned to either of the study groups.

Participation in this research is expected to last for 9 or more months.

Key Eligibility:

Open to men and women between 18 to 74 years
Participants must not have received prior treatment with CD47 or SIRPα-targeting agents or Antileukemic therapy (excluding hydroxyurea).

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Ellen K. Ritchie, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025799

ClinicalTrials.gov:

NCT05079230

Status

Open to Enrollment

Age Group

Adult

Disease

Leukemia

Acute Myeloid Leukemia