Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and duration of CR.

Official 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

Keywords

Myelodysplastic Syndromes Preleukemia Syndrome Azacitidine Hu5F9-G4 Magrolimab Magrolimab + Azacitidine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Previously untreated individuals with intermediate to very high risk Myelodysplastic Syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R)
  • Adequate performance status and hematological, liver, and kidney function

You CAN'T join if...

  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein
  • alpha (SIRPα)-targeting agents
  • Any prior antileukemic therapy
  • Contraindications to azacitidine
  • Clinical suspicion of active central nervous system (CNS) involvement by MDS
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
  • Pregnancy or active breastfeeding

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

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • University of Oklahoma Health Sciences Center accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04313881
Phase
Phase 3
Study Type
Interventional
Last Updated