Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated MDS
Trial Status: In Review
This is a randomized, double-blind, placebo-controlled multicenter study investigating magrolimab + azacitidine compared to placebo + azacitidine in previously untreated patients with intermediate / high / very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R). The Primary objective is to evaluate the efficacy of magrolimab + azacitidine, compared to that of placebo + azacitidine, in previously untreated patients with intermediate / high / very high risk MDS by IPSS-R as measured by Complete Remission (CR) and duration of CR.
- Previously untreated patients with intermediate to very high risk MDS by Revised International Prognostic Scoring System (IPSS-R)
- Adequate performance status and hematological, liver, and kidney function
- 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 CNS involvement by MDS
- Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
- Pregnancy or active breastfeeding
UCLA / Jonsson Comprehensive Cancer Center
Contact: Bruck Habtemariam
Emory University Hospital / Winship Cancer Institute
UNC Lineberger Comprehensive Cancer Center
Trial Phase Phase III
Trial Type Treatment
Forty Seven, Inc.
- Primary ID 5F9009
- Secondary IDs NCI-2020-03406
- Clinicaltrials.gov ID NCT04313881