Acute Myeloid Leukemia Clinical Trial
A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
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 AZA. Part 3 will be conducted in 2 phases - Dose Finding portion to determine RPTD of venetoclax in combination with CC-486 and Randomization portion to evaluate if venetoclax in combination with CC-486 as maintenance therapy improves relapse-free survival (RFS) compared to CC-486.
View Eligibility Criteria
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
History of acute promyelocytic leukemia (APL).
History of active central nervous system involvement with acute myeloid leukemia (AML).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
Submit
There are 155 Locations for this study
See Locations Near You
Mitchell Cancer Institute /ID# 216443
Mobile Alabama, 36604, United States
Mobile Alabama, 36604, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
Fountain Valley California, 92708, United States
Fountain Valley California, 92708, United States
University of California, Los Angeles /ID# 219149
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Colorado Blood Cancer Institute /ID# 214280
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
St. Alphonsus Regional Medical /ID# 216424
Boise Idaho, 83706, United States
Boise Idaho, 83706, United States
Rush University Medical Center /ID# 218815
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
University of Kentucky Markey Cancer Center /ID# 215048
Lexington Kentucky, 40536, United States
Lexington Kentucky, 40536, United States
Norton Cancer Institute /ID# 216401
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Tulane Medical Center - New Orleans /ID# 218166
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans Louisiana, 70121, United States
New Orleans Louisiana, 70121, United States
Tufts Medical Center /ID# 216110
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02111, United States
Massachusetts General Hospital /ID# 217307
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
UMass Chan Medical School /ID# 218163
Worcester Massachusetts, 01655, United States
Worcester Massachusetts, 01655, United States
Saint Louis University Cancer Center /ID# 218164
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
Springfield Missouri, 65807, United States
Springfield Missouri, 65807, United States
The John Theurer Cancer /ID# 215191
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey /ID# 239708
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08901, United States
Weill Cornell Medical College /ID# 214847
New York New York, 10065, United States
New York New York, 10065, United States
Providence Portland Medical Ct /ID# 216231
Portland Oregon, 97213, United States
Portland Oregon, 97213, United States
Fox Chase Cancer Center /ID# 239372
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19111, United States
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15232, United States
Prisma Health Cancer Institute-Faris Road /ID# 216066
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
St Francis Cancer Center /ID# 216115
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29607, United States
Gibbs Cancer Center & Research /ID# 216192
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Tennessee Oncology-Nashville Centennial /ID# 218757
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
Dallas Texas, 75246, United States
Dallas Texas, 75246, United States
University of Texas MD Anderson Cancer Center /ID# 225201
Houston Texas, 77030, United States
Houston Texas, 77030, United States
St George Hospital /ID# 215416
Kogarah New South Wales, 2217, Australia
Kogarah New South Wales, 2217, Australia
Liverpool Hospital /ID# 215415
Liverpool New South Wales, 2170, Australia
Liverpool New South Wales, 2170, Australia
Shoalhaven District Memorial Hospital /ID# 221973
Nowra New South Wales, 2541, Australia
Nowra New South Wales, 2541, Australia
Wollongong Hospital /ID# 216071
Wollongong New South Wales, 2500, Australia
Wollongong New South Wales, 2500, Australia
Gold coast University Hospital /ID# 214650
SouthPort Queensland, 4215, Australia
SouthPort Queensland, 4215, Australia
Toowoomba Hospital /ID# 217922
Toowoomba Queensland, 4350, Australia
Toowoomba Queensland, 4350, Australia
Princess Alexandra Hospital /ID# 238753
Woolloongabba Queensland, 4102, Australia
Woolloongabba Queensland, 4102, Australia
Royal Adelaide Hospital /ID# 238754
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Box Hill Hospital /ID# 217622
Box Hill Victoria, 3128, Australia
Box Hill Victoria, 3128, Australia
Barwon Health /ID# 217921
Geelong Victoria, 3220, Australia
Geelong Victoria, 3220, Australia
Perth Blood Institute Ltd /ID# 217531
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, 6009, Australia
Tom Baker Cancer Centre /ID# 214625
Calgary Alberta, T2N 4, Canada
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital - Division of Hematology /ID# 215656
Edmonton Alberta, T6G 2, Canada
Edmonton Alberta, T6G 2, Canada
Juravinski Cancer Centre /ID# 214623
Hamilton Ontario, L8V 1, Canada
Hamilton Ontario, L8V 1, Canada
London Health Sciences Center- University Hospital /ID# 216055
London Ontario, N6A 5, Canada
London Ontario, N6A 5, Canada
Ottawa Hospital Research Institute /ID# 214627
Ottawa Ontario, K1H 8, Canada
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre /ID# 214624
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G 2, Canada
McGill University Health Center Research Institute /ID# 215984
Montreal Quebec, H4A 3, Canada
Montreal Quebec, H4A 3, Canada
Beijing Friendship Hospital /ID# 216455
Beijing Beijing, 10003, China
Beijing Beijing, 10003, China
Chinese PLA General Hospital /ID# 216286
Beijing Beijing, 10085, China
Beijing Beijing, 10085, China
Guangdong Provincial People's Hospital /ID# 216284
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51008, China
Nanfang Hospital of Southern Medical University /ID# 215565
Guangzhou Guangdong, 51051, China
Guangzhou Guangdong, 51051, China
Henan Cancer Hospital /ID# 215566
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
Wuhan Hubei, 43002, China
Wuhan Hubei, 43002, China
Tongji Hospital Tongji Medical College of HUST /ID# 216456
Wuhan Hubei, 43003, China
Wuhan Hubei, 43003, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
Xi'an Shaanxi, 71003, China
Xi'an Shaanxi, 71003, China
Shanghai Tongji Hospital /ID# 218800
Shanghai Shanghai, 20006, China
Shanghai Shanghai, 20006, China
West China Hospital, Sichuan University /ID# 216606
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61004, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
Tianjin Tianjin, 30002, China
Tianjin Tianjin, 30002, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Peking University International Hospital /ID# 217439
Beijing , 10220, China
Beijing , 10220, China
Fakultni Nemocnice Brno /ID# 214807
Brno , 625 0, Czechia
Brno , 625 0, Czechia
Fakultni nemocnice Ostrava /ID# 214809
Ostrava , 708 5, Czechia
Ostrava , 708 5, Czechia
Ustav hematologie a krevni transfuze /ID# 215137
Praha , 128 0, Czechia
Praha , 128 0, Czechia
CHU de Nice - Hôpital Archet 1 /ID# 217368
Nice Alpes-Maritimes, 06200, France
Nice Alpes-Maritimes, 06200, France
CHU Bordeaux - Hopital Haut Leveque /ID# 215150
Pessac Gironde, 33604, France
Pessac Gironde, 33604, France
CHRU Lille - Hopital Claude Huriez /ID# 217474
Lille Hauts-de-France, 59037, France
Lille Hauts-de-France, 59037, France
Hopital Avicenne - APHP /ID# 215152
Bobigny Ile-de-France, 93000, France
Bobigny Ile-de-France, 93000, France
CHRU Tours - Hopital Bretonneau /ID# 216186
Tours CEDEX 9 Indre-et-Loire, 37044, France
Tours CEDEX 9 Indre-et-Loire, 37044, France
CHU de Nantes - Hotel Dieu /ID# 217367
Nantes Pays-de-la-Loire, 44000, France
Nantes Pays-de-la-Loire, 44000, France
Centre Hospitalier de la Cote Basque /ID# 216185
Bayonne Pyrenees-Atlantiques, 64100, France
Bayonne Pyrenees-Atlantiques, 64100, France
Centre Hospitalier du Mans /ID# 215148
Le Mans CEDEX 9 Sarthe, 72037, France
Le Mans CEDEX 9 Sarthe, 72037, France
Institut Gustave Roussy /ID# 215158
Villejuif Cedex Val-de-Marne, 94805, France
Villejuif Cedex Val-de-Marne, 94805, France
Chu Angers /Id# 215151
Angers , 49933, France
Angers , 49933, France
Hopital Henri Mondor /ID# 215159
Creteil , 94000, France
Creteil , 94000, France
Centre Hospitalier de Versailles André Mignot /ID# 215157
Le Chesnay , 78150, France
Le Chesnay , 78150, France
Universitaetsklinikum Leipzig /ID# 214440
Leipzig Sachsen, 04103, Germany
Leipzig Sachsen, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
Lübeck Schleswig-Holstein, 23538, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Klinikum Chemnitz gGmbH /ID# 216073
Chemnitz , 09116, Germany
Chemnitz , 09116, Germany
Universitaetsklinikum Halle (Saale) /ID# 221109
Halle (Saale) , 06120, Germany
Halle (Saale) , 06120, Germany
Universitaetsklinikum Giessen und Marburg /ID# 214734
Marburg , 35043, Germany
Marburg , 35043, Germany
General Hospital of Athens Laiko /ID# 213869
Athens Attiki, 11527, Greece
Athens Attiki, 11527, Greece
University General Hospital Attikon /ID# 214298
Athens Attiki, 12462, Greece
Athens Attiki, 12462, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 214075
Heraklion Kriti, 71500, Greece
Heraklion Kriti, 71500, Greece
General University Hospital of Alexandroupolis /ID# 213870
Alexandroupolis , 68100, Greece
Alexandroupolis , 68100, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
Athens , 10676, Greece
Athens , 10676, Greece
University General Hospital of Patras /ID# 213871
RION Patras Achaia , 26504, Greece
RION Patras Achaia , 26504, Greece
Debreceni Egyetem Klinikai Kozpont /ID# 214422
Debrecen Hajdu-Bihar, 4032, Hungary
Debrecen Hajdu-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
Kaposvár Somogy, 7400, Hungary
Kaposvár Somogy, 7400, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
Markusovszky Egyetemi Oktatokorhaz /ID# 215644
Szombathely Vas, 9700, Hungary
Szombathely Vas, 9700, Hungary
Semmelweis Egyetem /ID# 214423
Budapest , 1085, Hungary
Budapest , 1085, Hungary
Tel Aviv Sourasky Medical Center /ID# 239698
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 239700
Jerusalem Yerushalayim, 91120, Israel
Jerusalem Yerushalayim, 91120, Israel
Shaare Zedek Medical Center /ID# 239699
Jerusalem , 91031, Israel
Jerusalem , 91031, Israel
Rabin Medical Center /ID# 239696
Petakh Tikva , 49414, Israel
Petakh Tikva , 49414, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
Ancona , 60126, Italy
Ancona , 60126, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948
Bologna , 40138, Italy
Bologna , 40138, Italy
ASST Spedali civili di Brescia /ID# 214580
Brescia , 25123, Italy
Brescia , 25123, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
Catania , 95123, Italy
Catania , 95123, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
Milano , 20162, Italy
Milano , 20162, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
Milan , 20122, Italy
Milan , 20122, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
Napoli , 80131, Italy
Napoli , 80131, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 214278
Napoli , 80131, Italy
Napoli , 80131, Italy
Ospedale S.Eugenio /ID# 214277
Rome , 00144, Italy
Rome , 00144, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505
Turin , 10126, Italy
Turin , 10126, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
Nagoya-shi Aichi, 453-8, Japan
Nagoya-shi Aichi, 453-8, Japan
Aichi Cancer Center Hospital /ID# 215284
Nagoya-shi Aichi, 464-8, Japan
Nagoya-shi Aichi, 464-8, Japan
University of Fukui Hospital /ID# 215283
Yoshida-gun Fukui, 910-1, Japan
Yoshida-gun Fukui, 910-1, Japan
National Hospital Organization Kyushu Cancer Center /ID# 214841
Fukuoka-shi Fukuoka, 811-1, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Kyushu University Hospital /ID# 215286
Fukuoka-shi Fukuoka, 812-8, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Hokkaido University Hospital /ID# 215938
Sapporo-shi Hokkaido, 060-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
National Hospital Organization Mito Medical Center /ID# 214699
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
Tohoku University Hospital /ID# 214669
Sendai-shi Miyagi, 98085, Japan
Sendai-shi Miyagi, 98085, Japan
Nagasaki University Hospital /ID# 214916
Nagasaki-shi Nagasaki, 852-8, Japan
Nagasaki-shi Nagasaki, 852-8, Japan
Okayama University Hospital /ID# 214840
Okayama-shi Okayama, 700-8, Japan
Okayama-shi Okayama, 700-8, Japan
Osaka Metropolitan University Hospital /ID# 215225
Osaka-shi Osaka, 545-8, Japan
Osaka-shi Osaka, 545-8, Japan
Kindai University Hospital /ID# 214915
Osakasayama-shi Osaka, 589-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Saitama Medical University International Medical Center /ID# 214823
Hidaka-shi Saitama, 350-1, Japan
Hidaka-shi Saitama, 350-1, Japan
NTT Medical Center Tokyo /ID# 214959
Shinagawa-ku Tokyo, 141-8, Japan
Shinagawa-ku Tokyo, 141-8, Japan
Yamagata University Hospital /ID# 214698
Yamagata-shi Yamagata, 990-9, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seoul National University Bundang Hospital /ID# 215549
Seongnam Gyeonggido, 13620, Korea, Republic of
Seongnam Gyeonggido, 13620, Korea, Republic of
Pusan National University Hospital /ID# 213941
Busan , 49241, Korea, Republic of
Busan , 49241, Korea, Republic of
Seoul National University Hospital /ID# 213943
Seoul , 03080, Korea, Republic of
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 213940
Seoul , 06351, Korea, Republic of
Seoul , 06351, Korea, Republic of
Pan American Center for Oncology Trials, LLC /ID# 214953
Rio Piedras , 00935, Puerto Rico
Rio Piedras , 00935, Puerto Rico
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
Nizhniy Novgorod Nizhegorodskaya Oblast, 60312, Russian Federation
Nizhniy Novgorod Nizhegorodskaya Oblast, 60312, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
St. Petersburg Sankt-Peterburg, 19710, Russian Federation
St. Petersburg Sankt-Peterburg, 19710, Russian Federation
P. Hertsen Moscow Oncology Research Institute /ID# 214312
Moscow , 12528, Russian Federation
Moscow , 12528, Russian Federation
MMCC Kommunarka /ID# 215223
Moscow , 12930, Russian Federation
Moscow , 12930, Russian Federation
Clinic of Immunopathology, SRIFCI /ID# 217937
Novosibirsk , 63004, Russian Federation
Novosibirsk , 63004, Russian Federation
Almazov National Medical Research Centre /ID# 214306
Sankt-Peterburg , 19734, Russian Federation
Sankt-Peterburg , 19734, Russian Federation
Regional Clinical Hospital of Yaroslavl /ID# 214318
Yaroslavl , 15006, Russian Federation
Yaroslavl , 15006, Russian Federation
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
Hospitalet de Llobregat Barcelona, 08908, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Universitario de Navarra /ID# 214788
Pamplona Navarra, 31008, Spain
Pamplona Navarra, 31008, Spain
Hospital Santa Creu i Sant Pau /ID# 214714
Barcelona , 08041, Spain
Barcelona , 08041, Spain
Hospital Universitario Reina Sofia /ID# 214786
Cordoba , 14004, Spain
Cordoba , 14004, Spain
Hospital Universitario Infanta Leonor /ID# 214843
Madrid , 28031, Spain
Madrid , 28031, Spain
MD Anderson Madrid /ID# 214477
Madrid , 28033, Spain
Madrid , 28033, Spain
Hospital Universitario Ramon y Cajal /ID# 214684
Madrid , 28034, Spain
Madrid , 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
Madrid , 28040, Spain
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 214789
Madrid , 28041, Spain
Madrid , 28041, Spain
Hospital Universitario Virgen de la Victoria /ID# 214713
Malaga , 29010, Spain
Malaga , 29010, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
Kaohsiung , 807, Taiwan
Kaohsiung , 807, Taiwan
China Medical University Hospital /ID# 213952
Taichung , 40447, Taiwan
Taichung , 40447, Taiwan
National Taiwan University Hospital /ID# 213939
Taipei City , 100, Taiwan
Taipei City , 100, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213951
Taoyuan City , 333, Taiwan
Taoyuan City , 333, Taiwan
Erciyes University Medical Fac /ID# 214240
Melikgazi Kayseri, 38030, Turkey
Melikgazi Kayseri, 38030, Turkey
Gulhane Askeri Tip Academy /ID# 214242
Ankara , 06010, Turkey
Ankara , 06010, Turkey
Ankara Univ Medical Faculty /ID# 214239
Ankara , 06590, Turkey
Ankara , 06590, Turkey
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525
Istanbul , 34098, Turkey
Istanbul , 34098, Turkey
Karadeniz University /ID# 214241
Trabzon , 61000, Turkey
Trabzon , 61000, Turkey
University Hospitals Bristol /ID# 215911
Bristol Bristol, City Of, BS2 8, United Kingdom
Bristol Bristol, City Of, BS2 8, United Kingdom
Leicester Royal Infirmary /ID# 215924
Leicester England, LE1 5, United Kingdom
Leicester England, LE1 5, United Kingdom
Barts Health NHS Trust /ID# 215909
London London, City Of, E1 2E, United Kingdom
London London, City Of, E1 2E, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 215908
London London, City Of, SE1 9, United Kingdom
London London, City Of, SE1 9, United Kingdom
Cardiff & Vale University Health Board /ID# 215906
Cardiff Wales, CF14 , United Kingdom
Cardiff Wales, CF14 , United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
Birmingham , B15 2, United Kingdom
Birmingham , B15 2, United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 215921
London , NW1 2, United Kingdom
London , NW1 2, United Kingdom
How clear is this clinincal trial information?