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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.
Study identification
- NCT ID
- NCT03504410
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- CPI-613 + High Dose Cytarabine and Mitoxantrone Drug
- High Dose Cytarabine and Mitoxantrone Drug
- Mitoxantrone, Etoposide and Cytarabine Drug
- Fludarabine, Cytarabine, Filgrastim 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 12, 2018 (Actual)
- Primary completion
- Oct 25, 2021 (Actual)
- Completion
- Jan 19, 2022 (Actual)
- Last update posted
- Feb 8, 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 8, 2023 · Synced Oct 31, 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 public registry record, listed eligibility criteria, and available contact information for NCT03504410 live on ClinicalTrials.gov.