Acute Myeloid Leukemia Clinical Trial

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)

Summary

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 45 days.
Blast percentage in bone marrow before transplant must be < 10%.
Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.

Exclusion Criteria:

History of disease progression during prior treatment with venetoclax.
History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

424

Study ID:

NCT04161885

Recruitment Status:

Recruiting

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 161 Locations for this study

See Locations Near You

Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711
Scottsdale Arizona, 85258, United States
University of Arizona Cancer Center - Tucson /ID# 242507
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences /ID# 239804
Little Rock Arkansas, 72205, United States
City of Hope /ID# 213681
Duarte California, 91010, United States More Info
Site Coordinator
Contact
844-663-3742
University of California, Los Angeles /ID# 218199
Los Angeles California, 90095, United States More Info
Site Coordinator
Contact
844-663-3742
UCHSC Anschultz Cancer Pavilion /ID# 215618
Aurora Colorado, 80045, United States More Info
Site Coordinator
Contact
844-663-3742
Colorado Blood Cancer Institute /ID# 215980
Denver Colorado, 80218, United States More Info
Site Coordinator
Contact
844-663-3742
Memorial Cancer Institute /ID# 249792
Hollywood Florida, 33021, United States
Mayo Clinic /ID# 239710
Jacksonville Florida, 32224, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
Orlando Florida, 32804, United States More Info
Site Coordinator
Contact
844-663-3742
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840
Chicago Illinois, 60611, United States More Info
Site Coordinator
Contact
844-663-3742
The University of Chicago Medical Center /ID# 215616
Chicago Illinois, 60637, United States
Loyola University Medical Ctr /ID# 215617
Maywood Illinois, 60153, United States More Info
Site Coordinator
Contact
844-663-3742
Indiana Blood & Marrow Transpl /ID# 215842
Indianapolis Indiana, 46237, United States
Ochsner Clinic Foundation-New Orleans /ID# 213834
New Orleans Louisiana, 70121, United States More Info
Site Coordinator
Contact
844-663-3742
Greenebaum Comprehensive Cancer Center - UM /ID# 213855
Baltimore Maryland, 21201, United States More Info
Site Coordinator
Contact
844-663-3742
Massachusetts General Hospital /ID# 215765
Boston Massachusetts, 02114, United States More Info
Site Coordinator
Contact
844-663-3742
Karmanos Cancer Institute - Dresner Clinic /ID# 214581
Detroit Michigan, 48201, United States More Info
Site Coordinator
Contact
844-663-3742
Masonic Cancer Center /ID# 239492
Minneapolis Minnesota, 55455, United States
Mayo Clinic - Rochester /ID# 214685
Rochester Minnesota, 55905, United States More Info
Site Coordinator
Contact
844-663-3742
University of Mississippi Medical Center /ID# 239343
Jackson Mississippi, 39216, United States
The John Theurer Cancer /ID# 215251
Hackensack New Jersey, 07601, United States More Info
Site Coordinator
Contact
844-663-3742
Montefiore Medical Center - Moses Campus /ID# 241669
Bronx New York, 10467, United States
Roswell Park Comprehensive Cancer Center /ID# 217857
Buffalo New York, 14263, United States More Info
Site Coordinator
Contact
844-663-3742
Columbia University Medical Center /ID# 240875
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680
New York New York, 10065, United States
Weill Cornell Medical College /ID# 214887
New York New York, 10065, United States More Info
Site Coordinator
Contact
844-663-3742
University of North Carolina /ID# 215814
Chapel Hill North Carolina, 27514, United States
Wake Forest Univ HS /ID# 239210
Winston-Salem North Carolina, 27157, United States
UC Health - Cincinnati /ID# 239263
Cincinnati Ohio, 45267, United States
University Hospitals - Seidman Cancer Center /ID# 239260
Cleveland Ohio, 44106, United States
University of Oklahoma, Stephenson Cancer Center /ID# 215611
Oklahoma City Oklahoma, 73104, United States
Oregon Health & Science University /ID# 215874
Portland Oregon, 97239, United States More Info
Site Coordinator
Contact
844-663-3742
Penn State Hershey Medical Ctr /ID# 217120
Hershey Pennsylvania, 17033, United States More Info
Site Coordinator
Contact
844-663-3742
Children's Hospital of Philadelphia - Main /ID# 215410
Philadelphia Pennsylvania, 19104, United States
Perelman Center for Advanced Medicine - /ID# 214518
Philadelphia Pennsylvania, 19104, United States More Info
Site Coordinator
Contact
844-663-3742
Allegheny General Hospital /ID# 216756
Pittsburgh Pennsylvania, 15212, United States More Info
Site Coordinator
Contact
844-663-3742
UPMC Hillman Cancer Ctr /ID# 213715
Pittsburgh Pennsylvania, 15232, United States More Info
Site Coordinator
Contact
844-663-3742
St Jude Children's Research Hospital /ID# 214074
Memphis Tennessee, 38105, United States More Info
Site Coordinator
Contact
844-663-3742
TriStar Centennial Medical Center /ID# 218750
Nashville Tennessee, 37203, United States More Info
Site Coordinator
Contact
844-663-3742
Texas Oncology - Medical City Dallas /ID# 216720
Dallas Texas, 75230, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
Dallas Texas, 75246, United States More Info
Site Coordinator
Contact
844-663-3742
Texas Transplant Institute /ID# 214691
San Antonio Texas, 78229, United States More Info
Site Coordinator
Contact
844-663-3742
Virginia Commonwealth University Medical Center Main Hospital /ID# 239203
Richmond Virginia, 23219, United States
Fred Hutchinson Cancer Research Center /ID# 214436
Seattle Washington, 98109, United States More Info
Site Coordinator
Contact
844-663-3742
Univ of Wisconsin Hosp/Clinics /ID# 216096
Madison Wisconsin, 53792, United States More Info
Site Coordinator
Contact
608-265-4729
The Kinghorn Cancer Centre /ID# 214660
Darlinghurst New South Wales, 2010, Australia
Royal Adelaide Hospital /ID# 215678
Adelaide South Australia, 5000, Australia
Peter MacCallum Cancer Ctr /ID# 214653
Melbourne Victoria, 3000, Australia
Alfred Health /ID# 240931
Melbourne Victoria, 3004, Australia
Hospital de Clinicas de Porto Alegre /ID# 215042
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
Jaú Sao Paulo, 17210, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516
Sao Paulo , 05403, Brazil
Hospital Nove de Julho /ID# 242359
São Paulo , 01409, Brazil
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
Vancouver British Columbia, V5Z 1, Canada
Princess Margaret Cancer Centre /ID# 215344
Toronto Ontario, M5G 2, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
Montreal Quebec, H1T 2, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 215253
Montreal Quebec, H4A 3, Canada
Saskatoon Cancer Centre /ID# 238821
Saskatoon Saskatchewan, S7N 4, Canada
Peking University People's Hospital /ID# 215551
Beijing Beijing, 10004, China
Chinese PLA General Hospital /ID# 216287
Beijing Beijing, 10085, China
Aerospace Center Hospital /ID# 217018
Beijing Beijing, 86105, China
Fujian Medical University Union Hospital /ID# 215555
Fuzhou Fujian, 35000, China
Guangdong Provincial People's Hospital /ID# 218666
Guangzhou Guangdong, 51008, China
Zhujiang Hospital of Southern Medical University /ID# 216333
Guangzhou Guangdong, 51028, China
Nanfang Hospital of Southern Medical University /ID# 215553
Guangzhou Guangdong, 51051, China
Shenzhen Second People's Hospital /ID# 239401
Shenzhen Guangdong, 51802, China
Henan Cancer Hospital /ID# 215554
Zhengzhou Henan, 45000, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
Wuhan Hubei, 43002, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373
Wuhan Hubei, 43002, China
Xiangya Hospital Central South University /ID# 219025
Changsha Hunan, 41000, China
Zhongda Hospital Southeast University /ID# 218926
Nanjing Jiangsu, 21000, China
The First Affiliated Hospital of Soochow University /ID# 216605
Suzhou Jiangsu, 21500, China
The Affiliated Hospital of Xuzhou Medical University /ID# 239098
Xuzhou Jiangsu, 22100, China
The First Affiliated Hospital of Nanchang University /ID# 239168
Nanchang Jiangxi, 33000, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282
Xi'an Shaanxi, 71003, China
Shanghai Changhai Hospital /ID# 216334
Shanghai Shanghai, 20043, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
Tianjin Tianjin, 30002, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
Hangzhou Zhejiang, 31000, China
Fakultni Nemocnice Brno /ID# 214811
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove /ID# 214814
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava /ID# 239922
Ostrava , 708 5, Czechia
Ustav hematologie a krevni transfuze /ID# 215133
Praha , 128 0, Czechia
CHU de Nice - Hôpital Archet 1 /ID# 214056
Nice Alpes-Maritimes, 06200, France
CHU de Besancon - Jean Minjoz /ID# 241171
Besancon Doubs, 25030, France
CHU Bordeaux - Hopital Haut Leveque /ID# 214055
Pessac Gironde, 33604, France
CHRU Lille - Hopital Claude Huriez /ID# 217916
Lille Hauts-de-France, 59037, France
CHU de Nantes, Hotel Dieu -HME /ID# 214060
Nantes Pays-de-la-Loire, 44000, France
AP-HP - Hopital Saint-Louis /ID# 214054
Paris , 75010, France
AP-HP - Hopital Saint-Antoine /ID# 216957
Paris , 75012, France
Hopital Pitie Salpetriere /ID# 241072
Paris , 75013, France
Universitaetsklinik Heidelberg /ID# 216623
Heidelberg Baden-Wuerttemberg, 69120, Germany
Universitaetsklinikum Muenster /ID# 215213
Muenster Nordrhein-Westfalen, 48149, Germany
Universitaetsklinikum Leipzig /ID# 245892
Leipzig Sachsen, 04103, Germany
Klinikum Augsburg /ID# 239583
Augsburg , 86156, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244
Dresden , 01307, Germany
Universitaetsklinikum Halle (Saale) /ID# 239585
Halle (Saale) , 06120, Germany
Medizinische Hochschule Hannover /ID# 214243
Hannover , 30625, Germany
Universitaetsklinikum Wuerzburg /ID# 215212
Wuerzburg , 97080, Germany
General Hospital of Athens Evangelismos /ID# 238810
Athens Attiki, 10676, Greece
University General Hospital Attikon /ID# 238812
Athens Attiki, 12462, Greece
University General Hospital of Patras /ID# 238811
RION Patras Achaia , 26504, Greece
Debreceni Egyetem Klinikai Kozpont /ID# 241123
Debrecen Hajdu-Bihar, 4032, Hungary
The Chaim Sheba Medical Center /ID# 214305
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 214508
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 218697
Jerusalem Yerushalayim, 91120, Israel
Rambam Health Care Campus /ID# 214507
Haifa , 31096, Israel
Schneider Children's Medical Center /ID# 224326
Petah Tikva , 49202, Israel
Rabin Medical Center /ID# 214509
Petakh Tikva , 49414, Israel
Sheba Medical Center /ID# 239571
Tel Hashomer, Ramat Gan , 52621, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
Rome Lazio, 00168, Italy
Ospedale San Raffaele IRCCS /ID# 214311
Milan Milano, 20132, Italy
IEO -Istituto Europeo di Oncologia /ID# 242579
Milan Milano, 20141, Italy
ASST Spedali civili di Brescia /ID# 215997
Brescia , 25123, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148
Turin , 10126, Italy
Anjou Kousei Hospital /ID# 215857
Anjo-shi Aichi, 446-8, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
Nagoya-shi Aichi, 453-8, Japan
Kyushu University Hospital /ID# 215285
Fukuoka-shi Fukuoka, 812-8, Japan
Hokkaido University Hospital /ID# 215937
Sapporo-shi Hokkaido, 060-8, Japan
Kobe City Medical Center General Hospital /ID# 215388
Kobe-shi Hyogo, 650-0, Japan
Hyogo Medical University Hospital /ID# 215389
Nishinomiya-shi Hyogo, 663-8, Japan
Kanazawa University Hospital /ID# 242955
Kanazawa-shi Ishikawa, 920-8, Japan
Imamura General Hospital /ID# 215688
Kagoshima-shi Kagoshima, 890-0, Japan
Tokai University Hospital /ID# 250086
Isehara-shi Kanagawa, 259-1, Japan
Kanagawa Cancer Center /ID# 215029
Yokohama-shi Kanagawa, 241-8, Japan
Kyoto University Hospital /ID# 243209
Kyoto-shi Kyoto, 606-8, Japan
Tohoku University Hospital /ID# 214670
Sendai-shi Miyagi, 98085, Japan
Okayama University Hospital /ID# 214842
Okayama-shi Okayama, 700-8, Japan
Osaka Metropolitan University Hospital /ID# 215227
Osaka-shi Osaka, 545-8, Japan
Kindai University Hospital /ID# 214917
Osakasayama-shi Osaka, 589-8, Japan
Jichi Medical University Saitama Medical Center /ID# 216092
Saitama-shi Saitama, 330-8, Japan
Jichi Medical University Hospital /ID# 216091
Shimotsuke-shi Tochigi, 329-0, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
Bunkyo-ku Tokyo, 113-8, Japan
National Cancer Center Hospital /ID# 242639
Chuo-ku Tokyo, 104-0, Japan
Toranomon Hospital /ID# 215311
Minato-ku Tokyo, 105-8, Japan
National Center for Child Health and Development /ID# 242479
Setagaya-ku Tokyo, 157-8, Japan
Keio University Hospital /ID# 243549
Shinjuku-ku Tokyo, 160-8, Japan
Seoul National University Hospital /ID# 214891
Seoul , 03080, Korea, Republic of
Asan Medical Center /ID# 214893
Seoul , 05505, Korea, Republic of
Samsung Medical Center /ID# 239087
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892
Seoul , 06591, Korea, Republic of
Hospital Clinic de Barcelona /ID# 215108
Barcelona , 08036, Spain
Hospital Santa Creu i Sant Pau /ID# 240397
Barcelona , 08041, Spain
Hospital General Universitario Gregorio Maranon /ID# 215107
Madrid , 28007, Spain
Hospital Universitario Ramon y Cajal /ID# 218102
Madrid , 28034, Spain
Hospital Universitario La Paz /ID# 218103
Madrid , 28046, Spain
Hospital Universitario Virgen del Rocio /ID# 215463
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia /ID# 215106
Valencia , 46010, Spain
Universitätsspital Basel /ID# 215892
Basel Basel-Stadt, 4031, Switzerland
Universitatsspital Zurich /ID# 215891
Zurich Zuerich, 8091, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
Kaohsiung , 807, Taiwan
China Medical University Hospital /ID# 215198
Taichung City , 40447, Taiwan
Taichung Veterans General Hospital /ID# 239288
Taichung , 40705, Taiwan
National Taiwan University Hospital /ID# 215245
Taipei City , 100, Taiwan
Taipei Veterans General Hosp /ID# 239289
Taipei City , 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 215319
Taoyuan City , 333, Taiwan
University Hospital Southampton NHS Foundation Trust /ID# 244849
Southampton Hampshire, SO16 , United Kingdom
NHS Greater Glasgow and Clyde /ID# 215663
Glasgow Scotland, G12 0, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215120
Birmingham , B15 2, United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 215662
London , NW1 2, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 215338
London , SE5 9, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 215124
London , SW3 6, United Kingdom
Imperial College Healthcare NHS Trust /ID# 215665
London , W2 1N, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

424

Study ID:

NCT04161885

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.