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NCT01804101 · ClinicalTrials.gov registry record · NA

Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia

A NA study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
NA
Development phase
48
Enrollment target

NCT01804101: Completed NA study, sponsored by Fred Hutchinson Cancer Center.

NCT01804101 is a NA study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01804101, a NA study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target

Study Summary

This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Primary Outcome

Estimate whether the 32 units/m2 or the 64 units/m2 or both dose levels of CPX-351 are likely to improve treatment-related mortality (TRM) rate while keeping the CR rate constant in patients with untreated high-risk MDS or non-APL AML at high risk of TRM.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Liposomal Cytarabine-Daunorubicin CPX-351

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2013-05-07
Est. Completion 2017-01-10
Phase NA
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT01804101 record still lists

NCT01804101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT01804101 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01804101 about?

NCT01804101 is a clinical study titled "Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia". This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to stop the growth of cancer ...

What is the current status of trial NCT01804101?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2013-05-07. Estimated completion is 2017-01-10.

What interventions are being tested in trial NCT01804101?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Liposomal Cytarabine-Daunorubicin CPX-351 (DRUG).

Who is sponsoring clinical trial NCT01804101?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01804101's enrollment target sits among peer trials

48 1381st of 2000 higher than 601 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01804101, the US trial registry maintained by the National Library of Medicine. NCT01804101 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.