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NCT04190550 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
24
Enrollment target
6
Study locations

NCT04190550: Active Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).

NCT04190550 is a Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04190550, a Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
6
Study locations

Study Summary

This phase Ib trial studies the side effects and best dose of navtemadlin when given together with the standard chemotherapy drugs cytarabine and idarubicin in patients with acute myeloid leukemia. Navtemadlin may stop the growth of cancer cells by blocking a protein called MDM2 that is needed for cell growth. Chemotherapy drugs, 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. Giving navtemadlin with cytarabine and idarubicin may stabilize cancer for longer when compared to giving usual treatments alone.

Primary Outcome

Toxicity will be coded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Based on the toxicity observed, a derived variable, the occurrence of dose limiting toxicity, will be created. Toxicities will be tabulated and reported according to dose level, grade, type, cycle, and attribution and, if numbers permit, by whether the patient had newly diagnosed or previously treated acute myeloid leukemia (AML). Cumulative incidence curves will be used to estimate the pr

Conditions Studied

Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Interventions

  • DRUG Cytarabine
  • DRUG Navtemadlin
  • DRUG Idarubicin Hydrochloride

Study Locations (6)

California

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

Illinois

  • Northwestern University - Chicago

Maryland

  • University of Maryland/Greenebaum Cancer Center - Baltimore

New York

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-02-04
Est. Completion 2026-06-30
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04190550 still lists

NCT04190550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower).

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cytarabine is the first listed.

NCT04190550 lists 6 locations in 5 states (California, Illinois, Maryland).

Frequently Asked Questions

What is clinical trial NCT04190550 about?

NCT04190550 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia". This phase Ib trial studies the side effects and best dose of navtemadlin when given together with the standard chemotherapy drugs cytarabine and idarubicin in patients with acute myeloid leukemia. Navtemadlin may stop the growth of cancer cells by blocking a protein called MDM2 that is needed for c...

What is the current status of trial NCT04190550?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-02-04. Estimated completion is 2026-06-30.

What conditions does trial NCT04190550 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome.

What interventions are being tested in trial NCT04190550?

The interventions under investigation include: Cytarabine (DRUG), Navtemadlin (DRUG), Idarubicin Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT04190550?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04190550 being conducted?

This trial has 6 study locations across California, Illinois, Maryland, New York, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

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 NCT04190550's enrollment target sits among peer trials

24 225th of 306 higher than 75 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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 NCT04190550, the US trial registry maintained by the National Library of Medicine. NCT04190550 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.