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
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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).
Study identification
- NCT ID
- NCT03850535
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
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 25, 2019 (Actual)
- Primary completion
- Sep 10, 2020 (Actual)
- Completion
- Sep 10, 2020 (Actual)
- Last update posted
- Jun 21, 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 21, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03850535 live on ClinicalTrials.gov.