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
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Registration Number
- NCT04102020
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
-
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.
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Confirmation Venetoclax Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles. Part 1: Dose Confirmation Azacitidine Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles. Part 3 (Dose Finding): Dose Escalation Venetoclax Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD). Part 3 (Dose Finding): Dose Escalation Azacitidine Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD). Part 3 (Dose Finding): Safety Expansion Venetoclax Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD. Part 3 (Dose Finding): Safety Expansion Azacitidine Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
- Primary Outcome Measures
Name Time Method Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (AZA) (Part 1) Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Number of Participants With DLTs of Venetoclax in Combination with Oral AZA (Part 3 Dose Finding Portion) Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months. DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with oral AZA as described in the protocol and evaluated by the Investigator and the sponsor.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (156)
The John Theurer Cancer /ID# 215191
🇺🇸Hackensack, New Jersey, United States
University of California, Los Angeles /ID# 219149
🇺🇸Los Angeles, California, United States
Duplicate_Rush University Medical Center /ID# 218815
🇺🇸Chicago, Illinois, United States
UPMC Hillman Cancer Ctr /ID# 214051
🇺🇸Pittsburgh, Pennsylvania, United States
Massachusetts General Hospital /ID# 217307
🇺🇸Boston, Massachusetts, United States
General Hospital of Athens Laiko /ID# 213869
🇬🇷Athens, Attiki, Greece
University General Hospital Attikon /ID# 214298
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 214075
🇬🇷Heraklion, Kriti, Greece
General University Hospital of Alexandroupolis /ID# 213870
🇬🇷Alexandroupolis, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
🇬🇷Athens, Greece
Mitchell Cancer Institute /ID# 216443
🇺🇸Mobile, Alabama, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
🇺🇸Fountain Valley, California, United States
University of Kentucky Markey Cancer Center /ID# 215048
🇺🇸Lexington, Kentucky, United States
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
🇺🇸Greenville, South Carolina, United States
Henan Cancer Hospital /ID# 215566
🇨🇳Zhengzhou, Henan, China
Box Hill Hospital /ID# 217622
🇦🇺Box Hill, Victoria, Australia
Perth Blood Institute Ltd /ID# 217531
🇦🇺Nedlands, Western Australia, Australia
Tongji Hospital Tongji Medical College of HUST /ID# 216456
🇨🇳Wuhan, Hubei, China
Centre Hospitalier de Versailles André Mignot /ID# 215157
🇫🇷Le Chesnay, France
University General Hospital of Patras /ID# 213871
🇬🇷RION Patras Achaia, Greece
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
🇨🇦Edmonton, Alberta, Canada
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
🇺🇸Springfield, Missouri, United States
Tufts Medical Center /ID# 216110
🇺🇸Boston, Massachusetts, United States
Tom Baker Cancer Centre /ID# 214625
🇨🇦Calgary, Alberta, Canada
Wollongong Hospital /ID# 216071
🇦🇺Wollongong, New South Wales, Australia
Barwon Health /ID# 217921
🇦🇺Geelong, Victoria, Australia
Juravinski Cancer Centre /ID# 214623
🇨🇦Hamilton, Ontario, Canada
Shoalhaven District Memorial Hospital /ID# 221973
🇦🇺Nowra, New South Wales, Australia
London Health Sciences Center- University Hospital /ID# 216055
🇨🇦London, Ontario, Canada
Chu Angers /Id# 215151
🇫🇷Angers, France
St George Hospital /ID# 215416
🇦🇺Kogarah, New South Wales, Australia
Peking University International Hospital /ID# 217439
🇨🇳Beijing, Guizhou, China
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948
🇮🇹Bologna, Italy
Rabin Medical Center /ID# 239696
🇮🇱Haifa, Israel
Yamagata University Hospital /ID# 214698
🇯🇵Yamagata-shi, Yamagata, Japan
MMCC Kommunarka /ID# 215223
🇷🇺Moscow, Russian Federation
Duplicate_Hopital Henri Mondor /ID# 215159
🇫🇷Creteil, France
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
🇭🇺Szombathely, Vas, Hungary
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
🇮🇹Catania, Italy
Ospedale S.Eugenio /ID# 214277
🇮🇹Rome, Italy
Shaare Zedek Medical Center /ID# 239699
🇮🇱Jerusalem, Yerushalayim, Israel
Chinese PLA General Hospital /ID# 216286
🇨🇳Beijing, Beijing, China
Hokkaido University Hospital /ID# 215938
🇯🇵Sapporo-shi, Hokkaido, Japan
Universitaetsklinikum Halle (Saale) /ID# 221109
🇩🇪Halle (Saale), Germany
Pan American Center for Oncology Trials, LLC /ID# 214953
🇵🇷Rio Piedras, Puerto Rico
AOU Citta della Salute e della Scienza di Torino /ID# 214505
🇮🇹Torino, Piemonte, Italy
Seoul National University Hospital /ID# 213943
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
National Hospital Organization Mito Medical Center /ID# 214699
🇯🇵Higashi Ibaraki-gun, Ibaraki, Japan
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
🇭🇺Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
🇯🇵Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 215284
🇯🇵Nagoya-shi, Aichi, Japan
Semmelweis Egyetem /ID# 214423
🇭🇺Budapest, Hungary
National Hospital Organization Kyushu Cancer Center /ID# 214841
🇯🇵Fukuoka-shi, Fukuoka, Japan
Azienda Ospedaliera Universitaria Federico II /ID# 214278
🇮🇹Napoli, L Aquila, Italy
Universitaetsklinikum Leipzig /ID# 214440
🇩🇪Leipzig, Sachsen, Germany
ASST Spedali civili di Brescia /ID# 214580
🇮🇹Brescia, Italy
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
🇭🇺Kaposvár, Somogy, Hungary
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
🇬🇧Birmingham, United Kingdom
Hospital Universitario Virgen de la Victoria /ID# 214713
🇪🇸Malaga, Spain
Nagasaki University Hospital /ID# 214916
🇯🇵Nagasaki-shi, Nagasaki, Japan
Linkou Chang Gung Memorial Hospital /ID# 213951
🇨🇳Taoyuan City, Taiwan
P. Hertsen Moscow Oncology Research Institute /ID# 214312
🇷🇺Moscow, Russian Federation
Hospital Santa Creu i Sant Pau /ID# 214714
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Leonor /ID# 214843
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
🇪🇸Madrid, Spain
Almazov National Medical Research Centre /ID# 214306
🇷🇺Sankt-Peterburg, Russian Federation
Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Regional Clinical Hospital of Yaroslavl /ID# 214318
🇷🇺Yaroslavl, Kurskaya Oblast, Russian Federation
University College London Hospitals NHS Foundation Trust /ID# 215921
🇬🇧London, United Kingdom
Duplicate_Hospital Universitario Reina Sofia /ID# 214786
🇪🇸Cordoba, Spain
MD Anderson Madrid /ID# 214477
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal /ID# 214684
🇪🇸Madrid, Spain
Barts Health NHS Trust /ID# 215909
🇬🇧London, London, City Of, United Kingdom
Ankara Univ Medical Faculty /ID# 214239
🇹🇷Ankara, Turkey
Erciyes University Medical Faculty /ID# 214240
🇹🇷Kayseri, Turkey
Hospital Universitario 12 de Octubre /ID# 214789
🇪🇸Madrid, Spain
Hospital Universitario de Navarra /ID# 214788
🇪🇸Pamplona, Navarra, Spain
Gulhane Askeri Tip Academy /ID# 214242
🇹🇷Ankara, Adana, Turkey
Klinikum Chemnitz gGmbH /ID# 216073
🇩🇪Chemnitz, Saarland, Germany
Universitaetsklinikum Giessen und Marburg /ID# 214734
🇩🇪Marburg, Saarland, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
🇩🇪Lübeck, Schleswig-Holstein, Germany
Karadeniz University /ID# 214241
🇹🇷Trabzon, Adana, Turkey
Tennessee Oncology-Nashville Centennial /ID# 218757
🇺🇸Nashville, Tennessee, United States
China Medical University Hospital /ID# 213952
🇨🇳Taichung, Taiwan
CHU de Nice - Hôpital Archet 1 /ID# 217368
🇫🇷Nice, Alpes-Maritimes, France
CHU de Nantes - Hotel Dieu /ID# 217367
🇫🇷Nantes, Pays-de-la-Loire, France
Cardiff & Vale University Health Board /ID# 215906
🇬🇧Cardiff, Wales, United Kingdom
Centre Hospitalier du Mans /ID# 215148
🇫🇷Le Mans CEDEX 9, Sarthe, France
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
🇨🇳Kaohsiung, Keelung, Taiwan
Leicester Royal Infirmary /ID# 215924
🇬🇧Leicester, England, United Kingdom
NTT Medical Center Tokyo /ID# 214959
🇯🇵Shinagawa-ku, Tokyo, Japan
Colorado Blood Cancer Institute /ID# 214280
🇺🇸Denver, Colorado, United States
West China Hospital, Sichuan University /ID# 216606
🇨🇳Chengdu, Sichuan, China
Beijing Friendship Hospital /ID# 216455
🇨🇳Beijing, Beijing, China
Duplicate_Shanghai Tongji Hospital /ID# 218800
🇨🇳Shanghai, Shanghai, China
Providence Portland Medical Ct /ID# 216231
🇺🇸Portland, Oregon, United States
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525
🇹🇷Istanbul, Turkey
Hopital Avicenne - APHP /ID# 215152
🇫🇷Bobigny, Ile-de-France, France
University Hospitals Bristol /ID# 215911
🇬🇧Bristol, Bristol, City Of, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 215908
🇬🇧London, London, City Of, United Kingdom
Princess Margaret Cancer Centre /ID# 214624
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Research Institute /ID# 214627
🇨🇦Ottawa, Ontario, Canada
McGill University Health Center Research Institute /ID# 215984
🇨🇦Montreal, Quebec, Canada
Tohoku University Hospital /ID# 214669
🇯🇵Sendai-shi, Miyagi, Japan
Duplicate_Okayama University Hospital /ID# 214840
🇯🇵Okayama-shi, Okayama, Japan
St. Alphonsus Regional Medical /ID# 216424
🇺🇸Boise, Idaho, United States
Duplicate_UMass Chan Medical School /ID# 218163
🇺🇸Worcester, Massachusetts, United States
Weill Cornell Medical College /ID# 214847
🇺🇸New York, New York, United States
Rutgers Cancer Institute of New Jersey /ID# 239708
🇺🇸New Brunswick, New Jersey, United States
St Francis Cancer Center /ID# 216115
🇺🇸Greenville, South Carolina, United States
Saint Louis University Cancer Center /ID# 218164
🇺🇸Saint Louis, Missouri, United States
Fox Chase Cancer Center /ID# 239372
🇺🇸Philadelphia, Pennsylvania, United States
Gibbs Cancer Center & Research /ID# 216192
🇺🇸Spartanburg, South Carolina, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
🇺🇸Dallas, Texas, United States
Liverpool Hospital /ID# 215415
🇦🇺Liverpool, New South Wales, Australia
University of Texas MD Anderson Cancer Center /ID# 225201
🇺🇸Houston, Texas, United States
Gold coast University Hospital /ID# 214650
🇦🇺SouthPort, Queensland, Australia
Royal Adelaide Hospital /ID# 238754
🇦🇺Adelaide, South Australia, Australia
Toowoomba Hospital /ID# 217922
🇦🇺Toowoomba, Queensland, Australia
Princess Alexandra Hospital /ID# 238753
🇦🇺Woolloongabba, Queensland, Australia
Guangdong Provincial People's Hospital /ID# 216284
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 215565
🇨🇳Guangzhou, Guangdong, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
🇨🇳Xi'an, Shanxi, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
🇨🇳Wuhan, Hubei, China
Ustav hematologie a krevni transfuze /ID# 215137
🇨🇿Praha, Czechia
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
🇫🇷Pessac, Gironde, France
Fakultni Nemocnice Ostrava /ID# 214809
🇨🇿Ostrava, Praha 17, Czechia
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
🇨🇳Tianjin, Tianjin, China
Fakultni nemocnice Brno /ID# 214807
🇨🇿Brno, Czechia
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
🇨🇳Hangzhou, Zhejiang, China
CHRU Tours - Hopital Bretonneau /ID# 216186
🇫🇷Tours CEDEX 9, Indre-et-Loire, France
CHRU Lille - Hopital Claude Huriez /ID# 217474
🇫🇷Lille, Nord, France
Institut Gustave Roussy /ID# 215158
🇫🇷Villejuif Cedex, Val-de-Marne, France
Centre Hospitalier de la Cote Basque /ID# 216185
🇫🇷Bayonne, Pyrenees-Atlantiques, France
Debreceni Egyetem-Klinikai Kozpont /ID# 214422
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Tel Aviv Sourasky Medical Center /ID# 239698
🇮🇱Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 239700
🇮🇱Jerusalem, Yerushalayim, Israel
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
🇮🇹Milan, Milano, Italy
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
🇮🇹Ancona, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
🇮🇹Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
🇮🇹Napoli, Italy
University of Fukui Hospital /ID# 215283
🇯🇵Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 215286
🇯🇵Fukuoka-shi, Fukuoka, Japan
Saitama Medical University International Medical Center /ID# 214823
🇯🇵Hidaka-shi, Saitama, Japan
Osaka Metropolitan University Hospital /ID# 215225
🇯🇵Osaka-shi, Osaka, Japan
Kindai University Hospital /ID# 214915
🇯🇵Osakasayama-shi, Osaka, Japan
Pusan National University Hospital /ID# 213941
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Seoul National University Bundang Hospital /ID# 215549
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Samsung Medical Center /ID# 213940
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Clinic of Immunopathology, SRIFCI /ID# 217937
🇷🇺Novosibirsk, Kurskaya Oblast, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
National Taiwan University Hospital /ID# 213939
🇨🇳Taipei City, Taipei, Taiwan
Duplicate_Norton Cancer Institute /ID# 216401
🇺🇸Louisville, Kentucky, United States
Tulane Medical Center - New Orleans /ID# 218166
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic Foundation-New Orleans /ID# 214583
🇺🇸New Orleans, Louisiana, United States