Clinical trialNCT04190550Active, not recruitingPhase 1Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment24Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Kevin R Kelly
City of Hope Comprehensive Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Los Angeles General Medical Center
Los Angeles, California, United States
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland/greenebaum Cancer Center
Baltimore, Maryland, United States
Laura and Isaac Perlmutter Cancer Center at Nyu Langone
New York, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cytarabine →Idarubicin →Navtemadlin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 4 Feb 2021
Primary completion: 30 Jun 2027
Completion: 30 Jun 2027
Last update posted: 11 Jun 2026
Registered enrollment: 24
Registry id: NCT04190550

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.