Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
Public ClinicalTrials.gov record NCT03504410. 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
Phase 3 Multicenter Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. Therapy and Control Sub-groups in Older Patients With R/R AML
Study identification
- NCT ID
- NCT03504410
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Cornerstone Pharmaceuticals
- Industry
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- CPI-613 + High Dose Cytarabine and Mitoxantrone Drug
- Fludarabine, Cytarabine, Filgrastim Drug
- High Dose Cytarabine and Mitoxantrone Drug
- Mitoxantrone, Etoposide and Cytarabine Drug
Drug
Eligibility (public fields only)
- Age range
- 50 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
- Nov 11, 2018
- Primary completion
- Oct 24, 2021
- Completion
- Jan 18, 2022
- Last update posted
- Feb 7, 2023
2018 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | — |
| Chao Family Comprehensive Cancer Center (University of California Irvine) | Orange | California | 92868 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| University of Iowa-Holden Cancer Care Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky | Lexington | Kentucky | 40436 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Atlantic Health System | Morristown | New Jersey | 07960 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Stony Brook University Hospital | Long Island City | New York | 11794 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| University of Texas - Southwestern Medical Center | Dallas | Texas | 75390 | — |
| MD Andrson Cancer Center | Houston | Texas | 77030 | — |
| Baylor Temple (BSW) | Temple | Texas | 76508 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
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 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03504410, 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 Feb 7, 2023 · Synced May 14, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03504410 live on ClinicalTrials.gov.