Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

  • Interventional
  • Recruiting
  • NCT04313881
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - 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

        Key Exclusion Criteria:

         - 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.

At a Glance

National Government IDNCT04313881

IRB#IRB20-0699

Lead SponsorGilead Sciences

Lead PhysicianRichard Larson

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting