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ACTIVE NOT RECRUITING
NCT03330821
PHASE1/PHASE2

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

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

Official title: Phase 1B/II Study of Escalating Doses of Pevonedistat (TAK-924, Formerly MLN4924) Administered in Combination With Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed High Risk Acute Myelogenous Leukemia (AML)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2018-04-18

Completion Date

2026-12-31

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Cytarabine

Given IV

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Pevonedistat

Given IV

OTHER

Pharmacological Study

Correlative studies

Locations (5)

University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Cleveland Clinic

Cleveland, Ohio, United States