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NCT04313881 · ClinicalTrials.gov registry record · Phase 3
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 539
- Enrollment target
NCT04313881: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT04313881 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 539 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04313881, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 539 participants
- Enrollment target
Study 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).
Primary Outcome
The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off.
Interventions
- DRUG Placebo
- DRUG Azacitidine
- DRUG Magrolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 539 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2023-09-13 |
| Phase | Phase 3 |
Why NCT04313881 stopped before completion
NCT04313881 is an interventional study that assigns participants to a tested intervention. The registered 539 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04313881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04313881 about?
NCT04313881 is a clinical study titled "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 Sco...
What is the current status of trial NCT04313881?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2020-09-09. Estimated completion is 2023-09-13.
What interventions are being tested in trial NCT04313881?
The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), Magrolimab (DRUG).
Who is sponsoring clinical trial NCT04313881?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04313881's enrollment target sits among peer trials
539 700th of 2000 higher than 1,301 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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