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NCT04425655 · ClinicalTrials.gov registry record · Phase 2

Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.

A Phase 2 study, sponsored by University of California, San Diego.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT04425655: Clinical Trial Phase 2 study, sponsored by University of California, San Diego.

NCT04425655 is a Phase 2 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04425655, a Phase 2 study, was terminated before completion, sponsored by University of California, San Diego.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.

Primary Outcome

Overall response rate after induction, defined as the sum of complete response (CR) rate and complete response with incomplete count recovery (CRi) rate after 1-2 cycles of induction therapy, in accordance with 2017 ELN criteria.

Interventions

  • DRUG Fludarabine
  • DRUG Vyxeos

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2020-08-05
Est. Completion 2022-07-01
Phase Phase 2
University of California, San Diego

775 total trials

Why NCT04425655 stopped before completion

NCT04425655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.

NCT04425655 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04425655 about?

NCT04425655 is a clinical study titled "Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.". This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.

What is the current status of trial NCT04425655?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2020-08-05. Estimated completion is 2022-07-01.

What interventions are being tested in trial NCT04425655?

The interventions under investigation include: Fludarabine (DRUG), Vyxeos (DRUG).

Who is sponsoring clinical trial NCT04425655?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04425655's enrollment target sits among peer trials

2 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04425655, the US trial registry maintained by the National Library of Medicine. NCT04425655 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.