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NCT03330821 · ClinicalTrials.gov registry record · Phase 1

Pevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Therapy-Related Acute Myeloid Leukemia, sponsored by University of Southern California.

Active
Registry status
Phase 1
Development phase
53
Enrollment target
5
Study locations

NCT03330821: Active Phase 1 study of Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Therapy-Related Acute Myeloid Leukemia, sponsored by University of Southern California.

NCT03330821 is a Phase 1 study of Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Therapy-Related Acute Myeloid Leukemia that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 53 participants, below the 61-participant average among 21 other Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials with a reported enrollment target (13% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03330821, a Phase 1 study of Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Therapy-Related Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by University of Southern California.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
53 participants
Enrollment target
5
Study locations

Study Summary

This phase Ib/II trial studies the side effects and best dose of pevonedistat and to see how well it works in combination with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, 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. Given pevonedistat, cytarabine, and idarubicin may work better in treating patients with acute myeloid leukemia.

Primary Outcome

Response will be assessed according to the 2017 European Leukemia Net Guidelines. The composite complete response rate will be calculated as the percentage of patients who have CR or CRi. Wilson 95% confidence interval will be provided.

Conditions Studied

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Therapy-Related Acute Myeloid Leukemia Acute Myeloid Leukemia With Myelodysplasia-Related Changes

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Cytarabine
  • DRUG Idarubicin
  • OTHER Pharmacological Study
  • DRUG Pevonedistat

Study Locations (5)

California

  • Los Angeles County-USC Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

Arizona

  • University of Arizona Cancer Center - North Campus - Tucson

Florida

  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2018-04-18
Est. Completion 2026-12-31
Phase Phase 1
University of Southern California

617 total trials

What the registry record for NCT03330821 still lists

NCT03330821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 61-participant average among 21 other Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials with a reported enrollment target (13% lower).

The record links to 3 conditions, with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT03330821 lists 5 locations in 4 states (California, Arizona, Florida).

Frequently Asked Questions

What is clinical trial NCT03330821 about?

NCT03330821 is a clinical study titled "Pevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia". This phase Ib/II trial studies the side effects and best dose of pevonedistat and to see how well it works in combination with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...

What is the current status of trial NCT03330821?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2018-04-18. Estimated completion is 2026-12-31.

What conditions does trial NCT03330821 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Therapy-Related Acute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes.

What interventions are being tested in trial NCT03330821?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Idarubicin (DRUG), Pharmacological Study (OTHER), Pevonedistat (DRUG).

Who is sponsoring clinical trial NCT03330821?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03330821 being conducted?

This trial has 5 study locations across Arizona, California, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03330821's enrollment target sits among peer trials

53 12th of 21 higher than 10 of 21 other Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome 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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Related registry views

Source: ClinicalTrials.gov NCT03330821, the US trial registry maintained by the National Library of Medicine. NCT03330821 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.