NCT04102020CompletedPhase 3
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 23 Sept 2019
- Start date
- 26 Mar 2020
- Primary completion date
- 29 Sept 2022
- Lead sponsor
- AbbVie
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04102020
- EU CT number
- 2023-507221-42-00
- EudraCT number
- 2019-002217-19
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 112
- From 26 Mar 2020 to the primary completion date, 29 Sept 2022
- 127 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Who the study is looking for
- Diagnosis of newly diagnosed acute myeloid leukemia (AML).
- Participant meets the following disease activity criteria:
- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
- Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
- AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
- Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (127)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital /ID# 238754 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Box Hill Hospital /ID# 217622 Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Barwon Health /ID# 217921 Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| St George Hospital /ID# 215416 Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Liverpool Hospital /ID# 215415 Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Perth Blood Institute Ltd /ID# 217531 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Shoalhaven District Memorial Hospital /ID# 221973 Coordinator of this site? Confirm its status | Nowra | Australia | Unknown status |
| Gold coast University Hospital /ID# 214650 Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Toowoomba Hospital /ID# 217922 Coordinator of this site? Confirm its status | Toowoomba | Australia | Unknown status |
| Wollongong Hospital /ID# 216071 Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| Princess Alexandra Hospital /ID# 238753 Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Tom Baker Cancer Centre /ID# 214625 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Juravinski Cancer Centre /ID# 214623 Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| London Health Sciences Center- University Hospital /ID# 216055 Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Duplicate_McGill University Health Center Research Institute /ID# 215984 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Research Institute /ID# 214627 Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| University Health Network_Princess Margaret Cancer Centre /ID# 214624 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Chinese PLA General Hospital /ID# 216286 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital /ID# 216455 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University International Hospital /ID# 217439 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital, Sichuan University /ID# 216606 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Guangdong Provincial People's Hospital /ID# 216284 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University /ID# 215565 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Duplicate_Shanghai Tongji Hospital /ID# 218800 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital Tongji Medical College of HUST /ID# 216456 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283 Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Henan Cancer Hospital /ID# 215566 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Poruba | Czechia | Completed |
| Institute Of Hematology And Blood Transfusion Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| University Hospitals Birmingham NHS Foundation Trust /ID# 215910 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University Hospitals Bristol /ID# 215911 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Cardiff & Vale University Health Board /ID# 215906 Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Leicester Royal Infirmary /ID# 215924 Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Completed |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Completed |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| Shaare Zedek Medical Center /ID# 239699 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 239700 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center /ID# 239696 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 239698 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kyushu University Hospital /ID# 215286 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Saitama Medical University International Medical Center /ID# 214823 Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Duplicate_National Hospital Organization Mito Medical Center /ID# 214699 Coordinator of this site? Confirm its status | Higashi Ibaraki-gun | Japan | Unknown status |
| Duplicate_Nagasaki University Hospital /ID# 214916 Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Aichi Cancer Center Hospital /ID# 215284 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Duplicate_Okayama University Hospital /ID# 214840 Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka Metropolitan University Hospital /ID# 215225 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital /ID# 214915 Coordinator of this site? Confirm its status | Osakasayama-shi | Japan | Unknown status |
| Duplicate_Hokkaido University Hospital /ID# 215938 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku University Hospital /ID# 214669 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| NTT Medical Center Tokyo /ID# 214959 Coordinator of this site? Confirm its status | Shinagawa-ku | Japan | Unknown status |
| Yamagata University Hospital /ID# 214698 Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| University of Fukui Hospital /ID# 215283 Coordinator of this site? Confirm its status | Yoshida-gun | Japan | Unknown status |
| Duplicate_Pusan National University Hospital /ID# 213941 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Seoul National University Bundang Hospital /ID# 215549 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Seoul National University Hospital /ID# 213943 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 213940 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pan American Center for Oncology Trials, LLC /ID# 214953 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| MMCC Kommunarka /ID# 215223 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| P. Hertsen Moscow Oncology Research Institute /ID# 214312 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309 Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Clinic of Immunopathology, SRIFCI /ID# 217937 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Almazov National Medical Research Centre /ID# 214306 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Regional Clinical Hospital of Yaroslavl /ID# 214318 Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital /ID# 213952 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 213939 Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital /ID# 213951 Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| St. Alphonsus Regional Medical /ID# 216424 Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Massachusetts General Hospital /ID# 217307 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tufts Medical Center /ID# 216110 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Duplicate_Rush University Medical Center /ID# 218815 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Colorado Blood Cancer Institute /ID# 214280 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| St Francis Cancer Center /ID# 216115 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| The John Theurer Cancer /ID# 215191 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| University of Texas MD Anderson Cancer Center /ID# 225201 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Kentucky Markey Cancer Center /ID# 215048 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of California, Los Angeles /ID# 219149 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Duplicate_Norton Cancer Institute /ID# 216401 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Mitchell Cancer Institute /ID# 216443 Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Tennessee Oncology-Nashville Centennial /ID# 218757 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey /ID# 239708 Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Tulane Medical Center - New Orleans /ID# 218166 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Weill Cornell Medical College /ID# 214847 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Fox Chase Cancer Center /ID# 239372 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UPMC Hillman Cancer Ctr /ID# 214051 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Providence Portland Medical Ct /ID# 216231 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Gibbs Cancer Center & Research /ID# 216192 Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Oncology Hematology Associates (OHA) - Springfield /ID# 216351 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Saint Louis University Cancer Center /ID# 218164 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Duplicate_UMass Chan Medical School /ID# 218163 Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| Ankara Univ Medical Faculty /ID# 214239 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gulhane Askeri Tip Academy /ID# 214242 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Erciyes University Medical Faculty /ID# 214240 Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| Karadeniz University /ID# 214241 Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.