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)

NCT04161885 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: M19-0632023-507222-17-00
• Study Type: interventional
• Target: 465
• Locations: 18 countries
• Sites: 165

Brief Summary

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).

Conditions

Acute Myeloid Leukemia (AML); Cancer

Keywords

Acute Myeloid Leukemia (AML); Venetoclax; Azacitidine; Stem Cell Transplantation (SCT); Best Support Care (BSC); Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)

  DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.

  Up to the first treatment cycle (28 days)

• Overall Survival (OS) (Part 2)

  OS is defined as the number of days from the date of randomization to the date of death from any cause.

  Up to 45 months after the first participant is randomized

Secondary Outcomes (9)

• Morphologic Relapse-Free Survival (RFS) (Part 2)

  Up to 39 months after the first participant is randomized

• Composite Relapse-Free Survival (RFS) (Part 2)

  Up to 39 months after the first participant is randomized

• Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)

  Up to 39 months after the first participant is randomized

• Graft-versus-Host Disease (GvHD) Rate (Part 2)

  Up to 39 months after the first participant is randomized

• Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)

  Up to 39 months after the first participant is randomized

Study Arms (3)

Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care

EXPERIMENTAL

Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)

Drug: Venetoclax; Drug: Azacitidine; Other: Best Supportive Care (BSC)

Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC

EXPERIMENTAL

Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).

Drug: Venetoclax; Drug: Azacitidine; Other: Best Supportive Care (BSC)

Part 2: Arm B - Best Supportive Care (BSC)

EXPERIMENTAL

Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)

Other: Best Supportive Care (BSC)

Interventions

Venetoclax DRUG

Tablet; Oral

Also known as: ABT-199, GDC-0199, VENCLEXTA

Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care; Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC

Azacitidine DRUG

Subcutaneous (SC) or intravenous (IV) injection

Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care; Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC

Best Supportive Care (BSC) OTHER

BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care; Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC; Part 2: Arm B - Best Supportive Care (BSC)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 60 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (165)

Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711

Scottsdale, Arizona, 85258-4547, United States

Location

University of Arizona Cancer Center - Tucson /ID# 242507

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences /ID# 239804

Little Rock, Arkansas, 72205, United States

Location

City of Hope /ID# 213681

Duarte, California, 91010, United States

Location

UCHSC Anschultz Cancer Pavilion /ID# 215618

Aurora, Colorado, 80045-2517, United States

Location

Colorado Blood Cancer Institute /ID# 215980

Denver, Colorado, 80218, United States

Location

Mayo Clinic /ID# 239710

Jacksonville, Florida, 32224, United States

Location

AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985

Orlando, Florida, 32804-5505, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medical Center /ID# 215616

Chicago, Illinois, 60637-1443, United States

Location

Loyola University Medical Ctr /ID# 215617

Maywood, Illinois, 60153, United States

Location

Indiana Blood & Marrow Transpl /ID# 215842

Indianapolis, Indiana, 46237, United States

Location

Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834

New Orleans, Louisiana, 70121, United States

Location

University of Maryland, Baltimore /ID# 213855

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital /ID# 215765

Boston, Massachusetts, 02114, United States

Location

Karmanos Cancer Institute - Dresner Clinic /ID# 214581

Detroit, Michigan, 48201-2013, United States

Location

Masonic Cancer Center /ID# 239492

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic - Rochester /ID# 214685

Rochester, Minnesota, 55905-0001, United States

Location

University of Mississippi Medical Center /ID# 239343

Jackson, Mississippi, 39216-4500, United States

Location

The John Theurer Cancer /ID# 215251

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute /ID# 217857

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center /ID# 240875

New York, New York, 10032-3729, United States

Location

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680

New York, New York, 10065-6007, United States

Location

Weill Cornell Medical College /ID# 214887

New York, New York, 10065, United States

Location

Montefiore Medical Center - Moses Campus /ID# 241669

The Bronx, New York, 10467, United States

Location

University of North Carolina /ID# 215814

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest Univ HS /ID# 239210

Winston-Salem, North Carolina, 27157, United States

Location

UC Health - Cincinnati /ID# 239263

Cincinnati, Ohio, 45267-2800, United States

Location

University Hospitals - Seidman Cancer Center /ID# 239260

Cleveland, Ohio, 44106-1716, United States

Location

University of Oklahoma, Stephenson Cancer Center /ID# 215611

Oklahoma City, Oklahoma, 73104-5418, United States

Location

Oregon Health and Science University /ID# 215874

Portland, Oregon, 97239, United States

Location

Penn State Hershey Medical Ctr /ID# 217120

Hershey, Pennsylvania, 17033-2360, United States

Location

Children's Hospital of Philadelphia - Main /ID# 215410

Philadelphia, Pennsylvania, 19104-4319, United States

Location

Perelman Center for Advanced Medicine /ID# 214518

Philadelphia, Pennsylvania, 19104, United States

Location

Duplicate_Allegheny General Hospital /ID# 216756

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Hillman Cancer Ctr /ID# 213715

Pittsburgh, Pennsylvania, 15232, United States

Location

TriStar Centennial Medical Center /ID# 218750

Nashville, Tennessee, 37203-1551, United States

Location

Texas Oncology - Medical City Dallas /ID# 216720

Dallas, Texas, 75230, United States

Location

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735

Dallas, Texas, 75246-2003, United States

Location

Texas Transplant Institute /ID# 214691

San Antonio, Texas, 78229, United States

Location

Virginia Commonwealth University Medical Center Main Hospital /ID# 239203

Richmond, Virginia, 23219, United States

Location

Fred Hutchinson Cancer Research Center /ID# 214436

Seattle, Washington, 98109-1024, United States

Location

Univ of Wisconsin Hosp/Clinics /ID# 216096

Madison, Wisconsin, 53792-0001, United States

Location

The Kinghorn Cancer Centre /ID# 214660

Darlinghurst, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital /ID# 215678

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Ctr /ID# 214653

Melbourne, Victoria, 3000, Australia

Location

The Alfred Hospital /ID# 240931

Melbourne, Victoria, 3004, Australia

Location

Hospital de Clinicas de Porto Alegre /ID# 215042

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145

Jaú, São Paulo, 17210-070, Brazil

Location

Hospital Nove de Julho /ID# 242359

São Paulo, São Paulo, 01409-001, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 239516

São Paulo, 05403-000, Brazil

Location

Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University Health Network_Princess Margaret Cancer Centre /ID# 215344

Toronto, Ontario, M5G 2M9, Canada

Location

CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital / McGill University Health Centre /ID# 215253

Montreal, Quebec, H4A 3J1, Canada

Location

Saskatoon Cancer Centre /ID# 238821

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Peking University People's Hospital /ID# 215551

Beijing, Beijing Municipality, 100044, China

Location

Chinese PLA General Hospital /ID# 216287

Beijing, Beijing Municipality, 100853, China

Location

Aerospace Center Hospital /ID# 217018

Beijing, Beijing Municipality, 861059, China

Location

Fujian Medical University Union Hospital /ID# 215555

Fuzhou, Fujian, 350001, China

Location

Guangdong Provincial People's Hospital /ID# 218666

Guangzhou, Guangdong, 510080, China

Location

Zhujiang Hospital of Southern Medical University /ID# 216333

Guangzhou, Guangdong, 510280, China

Location

Nanfang Hospital of Southern Medical University /ID# 215553

Guangzhou, Guangdong, 510515, China

Location

Shenzhen Second People's Hospital /ID# 239401

Shenzhen, Guangdong, 518039, China

Location

Henan Cancer Hospital /ID# 215554

Zhengzhou, Henan, 450008, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552

Wuhan, Hubei, 430022, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital Central South University /ID# 219025

Changsha, Hunan, 410008, China

Location

Zhongda Hospital Southeast University /ID# 218926

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Soochow University /ID# 216605

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical College /ID# 239098

Xuzhou, Jiangsu, 221006, China

Location

The First Affiliated Hospital of Nanchang University /ID# 239168

Nanchang, Jiangxi, 330006, China

Location

Shanghai Changhai Hospital /ID# 216334

Shanghai, Shanghai Municipality, 200433, China

Location

Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282

Xi’an, Shanxi, 710038, China

Location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550

Hangzhou, Zhejiang, 310003, China

Location

Fakultní Nemocnice Brno - Jihlavská /ID# 214811

Brno, Brno-mesto, 625 00, Czechia

Location

Fakultní nemocnice Hradec Králové - Sokolská /ID# 214814

Hradec Králové, Hradec Kralove, 500 05, Czechia

Location

Fakultni Nemocnice Ostrava /ID# 239922

Ostrava, Ostrava-mesto, 708 52, Czechia

Location

Ustav hematologie a krevni transfuze /ID# 215133

Prague, 128 00, Czechia

Location

Duplicate_CHU de Nice - Hôpital Archet 1 /ID# 214056

Nice, Alpes-Maritimes, 06200, France

Location

CHU de Besancon - Jean Minjoz /ID# 241171

Besançon, Doubs, 25030, France

Location

Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 214055

Pessac, Gironde, 33604, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 217916

Lille, Nord, 59037, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 214060

Nantes, Pays de la Loire Region, 44000, France

Location

Hôpital Saint-Louis /ID# 214054

Paris, 75010, France

Location

AP-HP - Hopital Saint-Antoine /ID# 216957

Paris, 75012, France

Location

Hopital Pitie Salpetriere /ID# 241072

Paris, Île-de-France Region, 75013, France

Location

Universitaetsklinik Heidelberg /ID# 216623

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum Augsburg /ID# 239583

Augsburg, Bavaria, 86156, Germany

Location

Universitaetsklinikum Wuerzburg /ID# 215212

Würzburg, Bavaria, 97080, Germany

Location

Universitaetsklinikum Muenster /ID# 215213

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 214244

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Leipzig /ID# 245892

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 239585

Halle, 06120, Germany

Location

Medizinische Hochschule Hannover /ID# 214243

Hanover, 30625, Germany

Location

General Hospital of Athens Evangelismos /ID# 238810

Athens, Attica, 10676, Greece

Location

University General Hospital Attikon /ID# 238812

Athens, Attica, 12462, Greece

Location

University General Hospital of Patras /ID# 238811

RION Patras Achaia, 26504, Greece

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 241123

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Schneider Children's Medical Center /ID# 224326

Petah Tikva, Central District, 4920235, Israel

Location

Rambam Health Care Campus /ID# 214507

Haifa, H_efa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 218697

Jerusalem, Jerusalem, 91120, Israel

Location

Sheba Medical Center /ID# 239571

Ramat Gan, Tel Aviv, 52621, Israel

Location

The Chaim Sheba Medical Center /ID# 214305

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 214508

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rabin Medical Center /ID# 214509

Petah Tikva, 4941492, Israel

Location

IRCCS Ospedale San Raffaele /ID# 214311

Milan, Milano, 20132, Italy

Location

Istituto Europeo Di Oncologia /ID# 242579

Milan, Milano, 20141, Italy

Location

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 216148

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964

Rome, Roma, 00161, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910

Rome, Roma, 00168, Italy

Location

ASST degli Spedali Civili di Brescia /ID# 215997

Brescia, 25123, Italy

Location

Anjou Kousei Hospital /ID# 215857

Anjo-shi, Aichi-ken, 446-8602, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679

Nagoya, Aichi-ken, 453-8511, Japan

Location

University of Fukui Hospital /ID# 253383

Yoshida-gun, Fukui, 910-1104, Japan

Location

Kyushu University Hospital /ID# 215285

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital /ID# 252293

Fukushima, Fukushima, 960-1295, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522

Hiroshima, Hiroshima, 730-8619, Japan

Location

Hokkaido University Hospital /ID# 215937

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe City Medical Center General Hospital /ID# 215388

Kobe, Hyōgo, 650-0047, Japan

Location

Hyogo Medical University Hospital /ID# 215389

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Kanazawa University Hospital /ID# 242955

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Imamura General Hospital /ID# 215688

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Tokai University Hospital /ID# 250086

Isehara, Kanagawa, 259-1193, Japan

Location

Kanagawa Cancer Center /ID# 215029

Yokohama, Kanagawa, 241-8515, Japan

Location

Kyoto University Hospital /ID# 243209

Kyoto, Kyoto, 606-8507, Japan

Location

Tohoku University Hospital /ID# 214670

Sendai, Miyagi, 9808574, Japan

Location

Okayama University Hospital /ID# 214842

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka Metropolitan University Hospital /ID# 215227

Osaka, Osaka, 545-8586, Japan

Location

Kindai University Hospital /ID# 214917

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Jichi Medical University Saitama Medical Center /ID# 216092

Saitama-shi, Saitama, 330-8503, Japan

Location

Jichi Medical University Hospital /ID# 216091

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

National Cancer Center Hospital /ID# 242639

Chuo-ku, Tokyo, 104-0045, Japan

Location

Toranomon Hospital /ID# 215311

Minato-ku, Tokyo, 105-8470, Japan

Location

National Center for Child Health and Development /ID# 242479

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Keio University Hospital /ID# 243549

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Yamagata University Hospital /ID# 253304

Yamagata, Yamagata, 990-9585, Japan

Location

Seoul National University Hospital /ID# 214891

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Asan Medical Center /ID# 214893

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 239087

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Hospital Clinic de Barcelona /ID# 215108

Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 240397

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 215107

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 218102

Madrid, 28034, Spain

Location

Hospital Universitario La Paz /ID# 218103

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 215463

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 215106

Valencia, 46010, Spain

Location

Duplicate_Universitätsspital Basel /ID# 215892

Basel, Canton of Basel-City, 4031, Switzerland

Location

University Hospital Zurich /ID# 215891

Zurich, Canton of Zurich, 8006, Switzerland

Location

National Taiwan University Hospital /ID# 215245

Taipei City, Taipei, 100, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital /ID# 215198

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital /ID# 239288

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hosp /ID# 239289

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 215319

Taoyuan, 333, Taiwan

Location

Hammersmith Hospital /ID# 215665

London, England, W12 0HS, United Kingdom

Location

Gartnavel General Hospital /ID# 215663

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

University College London Hospital /ID# 215662

London, Greater London, NW1 2BU, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 215120

Birmingham, B15 2TH, United Kingdom

Location

King's College Hospital NHS Foundation Trust /ID# 215338

London, SE5 9RS, United Kingdom

Location

The Royal Marsden NHS Foundation Trust /ID# 215124

London, SW3 6JJ, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359

Newcastle upon Tyne, NE3 3HD, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 13, 2019
• Study Start: February 26, 2020
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (43); IT (6); CH (2); FR (8); CA (5); CZ (4); KR (4); GR (3); IL (7); BR (4); DE (8); JP (26); GB (7); CN (20); AU (4); ES (7); HU (1); TW (6)