A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
Public ClinicalTrials.gov record NCT04266795. 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 Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.
Study identification
- NCT ID
- NCT04266795
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 164 participants
Conditions and interventions
Conditions
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
- Oct 12, 2020
- Primary completion
- Sep 5, 2022
- Completion
- Oct 5, 2025
- Last update posted
- Oct 20, 2025
2020 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| AdventHealth (Florida Hospital) - Transplant Institute | Orlando | Florida | 32804 | — |
| Norton Cancer Institute - Suburban | Louisville | Kentucky | 40207 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| HCA Midwest Health - SCRI - PPDS | Kansas City | Missouri | 64132 | — |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | — |
| Stony Brook Medicine | Stony Brook | New York | 11794 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514-4221 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | — |
| Intermountain LDS Hospital | Salt Lake City | Utah | 84143 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04266795, 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 Oct 20, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04266795 live on ClinicalTrials.gov.