A Study Comparing Magrolimab plus Azacitidine versus Azacitidine Alone in Previously Untreated Patients with Higher-Risk Myelodysplastic Syndrome

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Full Title

ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome (WIRB)

Purpose

Myelodysplastic syndromes (MDS) are a group of bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. The purpose of this study is to compare the effects of the investigational drug magrolimab in combination with azacitidine to those of azacitidine plus a placebo for the treatment of patients with higher-risk MDS who have not yet been treated and cannot receive standard therapies.

Magrolimab is designed to target and block a protein called CD47 which cancer cells use to protect themselves from the immune system. Blocking CD47 may enable the immune system to find and destroy MDS cells. Azactidine is an anticancer drug already used to treat MDS.

Patients in this study will be randomly assigned to receive azacitidine with either magrolimab or a placebo. The treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated higher-risk MDS and not be candidates for standard therapies.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Eytan Stein at 646-608-3749.

Protocol

20-478

Phase

III

Investigator

Co-Investigators