A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
Public ClinicalTrials.gov record NCT04161885. 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 Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Study identification
- NCT ID
- NCT04161885
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 465 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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
- Feb 26, 2020 (Actual)
- Primary completion
- Sep 23, 2025 (Actual)
- Completion
- Sep 23, 2025 (Actual)
- Last update posted
- Jun 4, 2026
2020 – 2025
United States locations
- U.S. sites
- 43
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711 | Scottsdale | Arizona | 85258-4547 | — |
| University of Arizona Cancer Center - Tucson /ID# 242507 | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences /ID# 239804 | Little Rock | Arkansas | 72205 | — |
| City of Hope /ID# 213681 | Duarte | California | 91010 | — |
| UCHSC Anschultz Cancer Pavilion /ID# 215618 | Aurora | Colorado | 80045-2517 | — |
| Colorado Blood Cancer Institute /ID# 215980 | Denver | Colorado | 80218 | — |
| Mayo Clinic Hospital Jacksonville /ID# 239710 | Jacksonville | Florida | 32224 | — |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985 | Orlando | Florida | 32804-5505 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 215840 | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center /ID# 215616 | Chicago | Illinois | 60637-1443 | — |
| Loyola University Medical Ctr /ID# 215617 | Maywood | Illinois | 60153 | — |
| Indiana Blood & Marrow Transpl /ID# 215842 | Indianapolis | Indiana | 46237 | — |
| Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834 | New Orleans | Louisiana | 70121 | — |
| University of Maryland, Baltimore /ID# 213855 | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital /ID# 215765 | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute - Dresner Clinic /ID# 214581 | Detroit | Michigan | 48201-2013 | — |
| Masonic Cancer Center /ID# 239492 | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic - Rochester /ID# 214685 | Rochester | Minnesota | 55905-0001 | — |
| University of Mississippi Medical Center /ID# 239343 | Jackson | Mississippi | 39216-4500 | — |
| The John Theurer Cancer /ID# 215251 | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute /ID# 217857 | Buffalo | New York | 14263 | — |
| Columbia University Medical Center /ID# 240875 | New York | New York | 10032-3729 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680 | New York | New York | 10065-6007 | — |
| Weill Cornell Medical College /ID# 214887 | New York | New York | 10065 | — |
| Montefiore Medical Center - Moses Campus /ID# 241669 | The Bronx | New York | 10467 | — |
| University of North Carolina /ID# 215814 | Chapel Hill | North Carolina | 27514 | — |
| Atrium Health Wake Forest Baptist Medical Center /ID# 239210 | Winston-Salem | North Carolina | 27157 | — |
| UC Health - Cincinnati /ID# 239263 | Cincinnati | Ohio | 45267-2800 | — |
| University Hospitals Cleveland Medical Center /ID# 239260 | Cleveland | Ohio | 44106 | — |
| University of Oklahoma, Stephenson Cancer Center /ID# 215611 | Oklahoma City | Oklahoma | 73104-5418 | — |
| Oregon Health and Science University /ID# 215874 | Portland | Oregon | 97239 | — |
| Penn State Hershey Medical Ctr /ID# 217120 | Hershey | Pennsylvania | 17033-2360 | — |
| Children's Hospital of Philadelphia - Main /ID# 215410 | Philadelphia | Pennsylvania | 19104-4319 | — |
| University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 214518 | Philadelphia | Pennsylvania | 19104 | — |
| Duplicate_Allegheny General Hospital /ID# 216756 | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Hillman Cancer Ctr /ID# 213715 | Pittsburgh | Pennsylvania | 15232 | — |
| TriStar Centennial Medical Center /ID# 218750 | Nashville | Tennessee | 37203-1551 | — |
| Texas Oncology - Medical City Dallas /ID# 216720 | Dallas | Texas | 75230 | — |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735 | Dallas | Texas | 75246-2003 | — |
| Texas Transplant Institute /ID# 214691 | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 239203 | Richmond | Virginia | 23219 | — |
| Fred Hutchinson Cancer Research Center /ID# 214436 | Seattle | Washington | 98109-1024 | — |
| Univ of Wisconsin Hosp/Clinics /ID# 216096 | Madison | Wisconsin | 53792-0001 | — |
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 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04161885, 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 4, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04161885 live on ClinicalTrials.gov.