ClinicalTrials.gov record
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
ClinicalTrials.gov ID: NCT03268954
Public ClinicalTrials.gov record NCT03268954. 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 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Study identification
- NCT ID
- NCT03268954
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 454 participants
Conditions and interventions
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
- Nov 28, 2017 (Actual)
- Primary completion
- May 28, 2021 (Actual)
- Completion
- Oct 14, 2024 (Actual)
- Last update posted
- Oct 29, 2025
2017 – 2024
United States locations
- U.S. sites
- 128
- U.S. states
- 21
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center - USOR | Daphne | Alabama | 36526 | — |
| Southern Cancer Center - USOR | Mobile | Alabama | 36607 | — |
| Southern Cancer Center - USOR | Mobile | Alabama | 36608 | — |
| Southern Cancer Center- USOR | Mobile | Alabama | 36608 | — |
| Southeastern Regional Medical Center - CTCA - PPDS | Goodyear | Arizona | 85338 | — |
| Arizona Oncology Associates (Orange HOPE) - USOR | Tucson | Arizona | 85704 | — |
| Arizona Oncology Associates (Rudasill HOPE) - USOR | Tucson | Arizona | 85704 | — |
| Arizona Oncology Associates (Wilmot HOPE) - USOR | Tucson | Arizona | 85711 | — |
| Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc | Corona | California | 92879 | — |
| Compassionate Cancer Care Medical Group Inc | Fountain Valley | California | 92708 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Emad Ibrahim, MD, Inc | Redlands | California | 92373 | — |
| Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc | Riverside | California | 92501 | — |
| Rocky Mountain Cancer Centers (Aurora) - USOR | Aurora | Colorado | 80012 | — |
| Rocky Mountain Cancer Centers (Boulder) - USOR | Boulder | Colorado | 80303 | — |
| Rocky Mountain Cancer Centers (Colorado Springs) - USOR | Colorado Springs | Colorado | 80907 | — |
| Quest Diagnostics, INC | Denver | Colorado | 80209 | — |
| Colorado Blood Cancer Institute - PPDS | Denver | Colorado | 80218 | — |
| Presbyterian Saint Lukes Medical Center Laboratory | Denver | Colorado | 80218 | — |
| Presbyterian/St. Luke's Medical Center | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers (Williams) - USOR | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers (Denver) - USOR | Denver | Colorado | 80220 | — |
| Kaiser Foundation Health Plan | Denver | Colorado | 80239 | — |
| Laboratory Corporation of America | Englewood | Colorado | 80112 | — |
| Rocky Mountain Cancer Centers (Lakewood) - USOR | Lakewood | Colorado | 80228 | — |
| Rocky Mountain Cancer Centers (Littleton) - USOR | Littleton | Colorado | 80120 | — |
| Rocky Mountain Cancer Centers (Lone Tree) - USOR | Lone Tree | Colorado | 80124 | — |
| Rocky Mountain Cancer Centers (Longmont) - USOR | Longmont | Colorado | 80501 | — |
| Rocky Mountain Cancer Centers (Parker) - USOR | Parker | Colorado | 80138 | — |
| Rocky Mountain Cancer Centers (Pueblo) - USOR | Pueblo | Colorado | 81008 | — |
| Rocky Mountain Cancer Centers (Thornton) - USOR | Thornton | Colorado | 80260 | — |
| Medstar Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Altamonte Springs | Florida | 32701 | — |
| SCRI Florida Cancer Specialists South | Bonita Springs | Florida | 34135 | — |
| SCRI Florida Cancer Specialists South | Bradenton | Florida | 34209 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Brandon | Florida | 33511 | — |
| SCRI Florida Cancer Specialists South | Cape Coral | Florida | 33914 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Clearwater | Florida | 33761 | — |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33905 | — |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33908 | — |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33916 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Gainesville | Florida | 32605 | — |
| Mayo Clinic Jacksonville - PPDS | Jacksonville | Florida | 32224 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Largo | Florida | 33770 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Lecanto | Florida | 34461 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Baptist Health System (N Kendall) - USOR | Miami | Florida | 33176 | — |
| SCRI Florida Cancer Specialists South | Naples | Florida | 34102 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | New Port Richey | Florida | 34655 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Ocala | Florida | 34471 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Orange City | Florida | 32763 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Orlando | Florida | 32806 | — |
| SCRI Florida Cancer Specialists South | Port Charlotte | Florida | 33980 | — |
| SCRI Florida Cancer Specialists South | Sarasota | Florida | 34232 | — |
| SCRI Florida Cancer Specialists South | Sarasota | Florida | 34236 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Spring Hill | Florida | 34608 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Tampa | Florida | 33607 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Tavares | Florida | 32778 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | The Villages | Florida | 32159 | — |
| SCRI Florida Cancer Specialists South | Venice | Florida | 34285 | — |
| SCRI Florida Cancer Specialists South | Venice | Florida | 34292 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | Winter Park | Florida | 32792 | — |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | — |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| Saint Alphonsus Caldwell Cancer Care Center | Caldwell | Idaho | 83605 | — |
| Saint Alphonsus Medical Center | Nampa | Idaho | 83687 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Menorah Medical Center | Overland Park | Kansas | 66209 | — |
| Centerpoint Medical Center | Independence | Missouri | 64057 | — |
| HCA Midwest Health - SCRI - PPDS | Kansas City | Missouri | 64132 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| New Jersey Hematology Oncology Associates LLC | Brick | New Jersey | 08724 | — |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| New Jersey Hematology and Oncology | Toms River | New Jersey | 08755 | — |
| Weill Cornell Medical Center - Monitoring Location | New York | New York | 10021 | — |
| Weill Cornell Medical Center | New York | New York | 10021 | — |
| Strong Memorial Hospital | Rochester | New York | 14642 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45211 | — |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45230 | — |
| Oncology Hematology Care Inc - USOR | Cincinnati | Ohio | 45236 | — |
| Oncology Hematology Care Inc - USOR | Cincinnati | Ohio | 45242 | — |
| Fairview Hospital | Cleveland | Ohio | 44111 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Oncology Hematology Care, Inc - Fairfield | Fairfield | Ohio | 45014 | — |
| Hillcrest Hospital Cancer Care Center | Mayfield | Ohio | 44124 | — |
| St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | — |
| St. Luke's University Health Network | Easton | Pennsylvania | 18045 | — |
| Greenville Health System | Easley | South Carolina | 29640 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Greenville Health System Cancer Institute | Greenville | South Carolina | 29615 | — |
| Greenville Health System | Greer | South Carolina | 29650 | — |
| Greenville Health System | Seneca | South Carolina | 29672 | — |
| Greenville Health System | Spartanburg | South Carolina | 29307 | — |
| Tennessee Oncology - DICKSON - SCRI - PPDS | Dickson | Tennessee | 37055 | — |
| Tennessee Oncology - FRANKLIN - SCRI - PPDS | Franklin | Tennessee | 37067 | — |
| Tennessee Oncology - GALLATIN - SCRI - PPDS | Gallatin | Tennessee | 37066 | — |
| Tennessee Oncology - SUMMIT - SCRI - PPDS | Hermitage | Tennessee | 37076 | — |
| Tennessee Oncology - LEBANON - SCRI - PPDS | Lebanon | Tennessee | 37090 | — |
| Tennessee Oncology - MURFREESBORO - SCRI - PPDS | Murfreesboro | Tennessee | 37129 | — |
| Sarah Cannon Center for Blood Centers - SCRI - PPDS | Nashville | Tennessee | 37203 | — |
| Tennessee Oncolgy - BAPTIST - SCRI - PPDS | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology NASH - SCRI - PPDS | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS | Nashville | Tennessee | 37205 | — |
| Tennessee Oncology SKYLINE - SCRI - PPDS | Nashville | Tennessee | 37207 | — |
| Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS | Nashville | Tennessee | 37211 | — |
| Tennessee Oncology - SHELBYVILLE - SCRI - PPDS | Shelbyville | Tennessee | 37160 | — |
| Tennessee Oncology - SMYRNA - SCRI - PPDS | Smyrna | Tennessee | 37167 | — |
| Texas Oncology (West 38) - USOR | Austin | Texas | 78705 | — |
| Texas Oncology (Balcones) - USOR | Austin | Texas | 78731 | — |
| Texas Oncology (James Casey) - USOR | Austin | Texas | 78745 | — |
| Texas Oncology (Medical City) - USOR | Dallas | Texas | 75230 | — |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Oncology (Tyler) - USOR | Longview | Texas | 75601 | — |
| Texas Oncology (E Common) - USOR | New Braunfels | Texas | 78130 | — |
| Texas Oncology (Round Rock) - USOR | Round Rock | Texas | 78681 | — |
| Texas Oncology - San Antonio Medical Center - USOR | San Antonio | Texas | 78240 | — |
| Texas Oncology (Tyler) - USOR | Tyler | Texas | 75702 | — |
| Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR | Blacksburg | Virginia | 24060 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR | Low Moor | Virginia | 24457 | — |
| Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR | Roanoke | Virginia | 24014 | — |
| Oncology and Hematology Associates of Southwest Virginia Inc | Salem | Virginia | 24153 | — |
| Oncology and Hematology Associates of Southwest Virginia | Wytheville | Virginia | 24382 | — |
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 114 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03268954, 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 29, 2025 · Synced Oct 28, 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 NCT03268954 live on ClinicalTrials.gov.