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NCT04778397 · ClinicalTrials.gov registry record · Phase 3

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

A Phase 3 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 3
Development phase
258
Enrollment target

NCT04778397: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.

NCT04778397 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 258 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04778397, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 3
Development phase
258 participants
Enrollment target

Study Summary

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Primary Outcome

OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG Magrolimab

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2021-07-01
Est. Completion 2024-03-25
Phase Phase 3
Gilead Sciences

504 total trials

Why NCT04778397 stopped before completion

NCT04778397 is an interventional study that assigns participants to a tested intervention. The registered 258 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 (67% lower).

The record links to 0 conditions, and to 5 interventions - of which Venetoclax is the first listed.

NCT04778397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04778397 about?

NCT04778397 is a clinical study titled "Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated". The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

What is the current status of trial NCT04778397?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 258 participants. The study started on 2021-07-01. Estimated completion is 2024-03-25.

What interventions are being tested in trial NCT04778397?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Magrolimab (DRUG).

Who is sponsoring clinical trial NCT04778397?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04778397's enrollment target sits among peer trials

258 1235th of 2000 higher than 763 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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Source: ClinicalTrials.gov NCT04778397, the US trial registry maintained by the National Library of Medicine. NCT04778397 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.