A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

ClinicalTrials.gov ID: NCT03850535

Public ClinicalTrials.gov record NCT03850535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 7:41 PM EDT

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Official title

A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

Study identification

NCT ID: NCT03850535
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 24 participants

Conditions and interventions

Conditions

Acute Myeloid Leukemia

Interventions

Idasanutlin Drug
Cytarabine Drug
Daunorubicin Drug
Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) Procedure

Drug · Procedure

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 24, 2019
Primary completion: Sep 9, 2020
Completion: Sep 9, 2020
Last update posted: Jun 20, 2022

2019 – 2020

United States locations

U.S. sites: 12
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California	90095	—
Sarah Cannon Research Institute at HealthONE	Denver	Colorado	80218	—
Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois	60637-1447	—
University of Iowa Hospitals and Clinics; Investigational Drug Services	Iowa City	Iowa	52242	—
University of Kansas Clinical Research Center; Clinical Trials Office	Fairway	Kansas	66205	—
Massachusetts General Hospital	Boston	Massachusetts	02114	—
State University of NY	Brooklyn	New York	11203	—
Icahn School of Medicine at Mount Sinai	New York	New York	10029	—
Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	27157	—
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	—
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	19107	—
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030-4009	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03850535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 20, 2022 · Synced Jul 23, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03850535 live on ClinicalTrials.gov.

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