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 overall survival (OS).

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, Magrolimab, Magrolimab + Azacitidine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
  • Adequate performance status and hematological, liver, and kidney function

You CAN'T join if...

  • Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor
  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents
  • Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year
  • 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 in medical history
  • Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening
  • 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
  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT04313881
Phase
Phase 3 Myelodysplastic Syndrome Research Study
Study Type
Interventional
Participants
Expecting 520 study participants
Last Updated