Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Magrolimab
  • Drug: Azacitidine
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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:

   - 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 (SIRPĪ±)-targeting agents

   - Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS
   per IPSS-R

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jack Taw
650-723-2781
Recruiting