Trials / Terminated
TerminatedNCT04313881
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 539 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Magrolimab | Administered intravenously |
| DRUG | Azacitidine | Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling |
| DRUG | Placebo | Placebo to match magrolimab administered intravenously |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2023-09-13
- Completion
- 2023-09-13
- First posted
- 2020-03-18
- Last updated
- 2024-06-27
- Results posted
- 2024-03-21
Locations
169 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04313881. Inclusion in this directory is not an endorsement.