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VIALE-T: 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)

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04161885
Collaborator
(none)
424
Enrollment
170
Locations
3
Arms
69.5
Anticipated Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
Actual Study Start Date :
Feb 26, 2020
Anticipated Primary Completion Date :
Sep 3, 2025
Anticipated Study Completion Date :
Dec 11, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care

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
Tablet; Oral
Other Names:
  • ABT-199
  • GDC-0199
  • VENCLEXTA

    • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection

    Other: Best Supportive Care (BSC)
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
    Experimental: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC

    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
    Tablet; Oral
    Other Names:
  • ABT-199
  • GDC-0199
  • VENCLEXTA

    • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection

    Other: Best Supportive Care (BSC)
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
    Experimental: Part 2: Arm B - Best Supportive Care (BSC)

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1) [Upto the first treatment cycle (28 days)]

      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.

    2. Relapse-Free Survival (RFS) (Part 2) [Up to 39 months after the first participant is randomized]

      RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.

    Secondary Outcome Measures

    1. Overall Survival (OS) (Part 2) [Up to 45 months after the first participant is randomized]

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

    2. Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2) [Up to 39 months after the first participant is randomized]

      GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR occurrence or worsening of GvHD OR death from any cause.

    3. Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2) [Up to 39 months after the first participant is randomized]

      Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause.

    4. Graft-versus-Host Disease (GvHD) rate (Part 2) [Up to 39 months after the first participant is randomized]

      GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator

    5. Change From Randomization in Fatigue in Adult Participants (Part 2) [Up to 39 months after the first participant is randomized]

      Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.

    6. Minimal Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2) [Up to 39 months after the first participant is randomized]

      MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.

    7. Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) [Up to 39 months after the first participant is randomized]

      The EORTC-QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participantts rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much)."

    8. Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) [Up to 39 months after the first participant is randomized]

      The EQ-5D-5L is a generic preference instrument that has been validated in numerous population and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-point scale: with higher scores representing better functioning/quality of life and greater symptom burden.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 30 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711 Scottsdale Arizona United States 85258-4547
    2 University of Arizona Cancer Center - Tucson /ID# 242507 Tucson Arizona United States 85724
    3 University of Arkansas for Medical Sciences /ID# 239804 Little Rock Arkansas United States 72205
    4 City of Hope /ID# 213681 Duarte California United States 91010
    5 University of California, Los Angeles /ID# 218199 Los Angeles California United States 90095
    6 UCHSC Anschultz Cancer Pavilion /ID# 215618 Aurora Colorado United States 80045-2517
    7 Colorado Blood Cancer Institute /ID# 215980 Denver Colorado United States 80218
    8 Mayo Clinic /ID# 239710 Jacksonville Florida United States 32224
    9 AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985 Orlando Florida United States 32804-5505
    10 Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840 Chicago Illinois United States 60611
    11 The University of Chicago Medical Center /ID# 215616 Chicago Illinois United States 60637-1443
    12 Loyola University Medical Ctr /ID# 215617 Maywood Illinois United States 60153
    13 Indiana Blood & Marrow Transpl /ID# 215842 Indianapolis Indiana United States 46237
    14 Ochsner Clinic Foundation-New Orleans /ID# 213834 New Orleans Louisiana United States 70121
    15 Greenebaum Comprehensive Cancer Center - UM /ID# 213855 Baltimore Maryland United States 21201-1544
    16 Massachusetts General Hospital /ID# 215765 Boston Massachusetts United States 02114
    17 Karmanos Cancer Institute - Dresner Clinic /ID# 214581 Detroit Michigan United States 48201-2013
    18 Masonic Cancer Center /ID# 239492 Minneapolis Minnesota United States 55455
    19 Mayo Clinic - Rochester /ID# 214685 Rochester Minnesota United States 55905-0001
    20 University of Mississippi Medical Center /ID# 239343 Jackson Mississippi United States 39216-4500
    21 Saint Louis University Cancer Center /ID# 239633 Saint Louis Missouri United States 63110-2539
    22 The John Theurer Cancer /ID# 215251 Hackensack New Jersey United States 07601
    23 Montefiore Medical Center - Moses Campus /ID# 241669 Bronx New York United States 10467
    24 Roswell Park Comprehensive Cancer Center /ID# 217857 Buffalo New York United States 14263
    25 Columbia University Medical Center /ID# 240875 New York New York United States 10032-3729
    26 Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680 New York New York United States 10065-6007
    27 Weill Cornell Medical College /ID# 214887 New York New York United States 10065
    28 University of North Carolina /ID# 215814 Chapel Hill North Carolina United States 27514
    29 Wake Forest Univ HS /ID# 239210 Winston-Salem North Carolina United States 27157
    30 UC Health - Cincinnati /ID# 239263 Cincinnati Ohio United States 45267-2800
    31 University Hospitals - Seidman Cancer Center /ID# 239260 Cleveland Ohio United States 44106-1716
    32 University of Oklahoma, Stephenson Cancer Center /ID# 215611 Oklahoma City Oklahoma United States 73104-5418
    33 Oregon Health & Science University /ID# 215874 Portland Oregon United States 97239-3011
    34 Penn State Hershey Medical Ctr /ID# 217120 Hershey Pennsylvania United States 17033-2360
    35 Children's Hospital of Philadelphia - Main /ID# 215410 Philadelphia Pennsylvania United States 19104-4319
    36 Perelman Center for Advanced Medicine - /ID# 214518 Philadelphia Pennsylvania United States 19104-5127
    37 Allegheny General Hospital /ID# 216756 Pittsburgh Pennsylvania United States 15212
    38 UPMC Hillman Cancer Ctr /ID# 213715 Pittsburgh Pennsylvania United States 15232
    39 St Jude Children's Research Hospital /ID# 214074 Memphis Tennessee United States 38105
    40 TriStar Centennial Medical Center /ID# 218750 Nashville Tennessee United States 37203-1551
    41 Texas Oncology - Medical City Dallas /ID# 216720 Dallas Texas United States 75230
    42 Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735 Dallas Texas United States 75246-2003
    43 Texas Transplant Institute /ID# 214691 San Antonio Texas United States 78229
    44 Virginia Commonwealth University Medical Center Main Hospital /ID# 239203 Richmond Virginia United States 23219
    45 Fred Hutchinson Cancer Research Center /ID# 214436 Seattle Washington United States 98109-1024
    46 Univ of Wisconsin Hosp/Clinics /ID# 216096 Madison Wisconsin United States 53792-0001
    47 The Kinghorn Cancer Centre /ID# 214660 Darlinghurst New South Wales Australia 2010
    48 Royal Adelaide Hospital /ID# 215678 Adelaide South Australia Australia 5000
    49 Peter MacCallum Cancer Ctr /ID# 214653 Melbourne Victoria Australia 3000
    50 Alfred Health /ID# 240931 Melbourne Victoria Australia 3004
    51 Hospital de Clinicas de Porto Alegre /ID# 215042 Porto Alegre Rio Grande Do Sul Brazil 90035-903
    52 Hospital Amaral Carvalho /ID# 215145 Jaú Sao Paulo Brazil 17210-070
    53 Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516 Sao Paulo Brazil 05403-000
    54 Hospital Nove de Julho /ID# 242359 São Paulo Brazil 01409-001
    55 Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363 Vancouver British Columbia Canada V5Z 1M9
    56 Princess Margaret Cancer Centre /ID# 215344 Toronto Ontario Canada M5G 2M9
    57 CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591 Montreal Quebec Canada H1T 2M4
    58 Royal Victoria Hospital / McGill University Health Centre /ID# 215253 Montreal Quebec Canada H4A 3J1
    59 Saskatoon Cancer Centre /ID# 238821 Saskatoon Saskatchewan Canada S7N 4H4
    60 Peking University People's Hospital /ID# 215551 Beijing Beijing China 100044
    61 Chinese PLA General Hospital /ID# 216287 Beijing Beijing China 100853
    62 Aerospace Center Hospital /ID# 217018 Beijing Beijing China 861059
    63 Fujian Medical University Union Hospital /ID# 215555 Fuzhou Fujian China 350001
    64 Guangdong Provincial People's Hospital /ID# 218666 Guangzhou Guangdong China 510080
    65 Zhujiang Hospital of Southern Medical University /ID# 216333 Guangzhou Guangdong China 510280
    66 Nanfang Hospital of Southern Medical University /ID# 215553 Guangzhou Guangdong China 510515
    67 Shenzhen Second People's Hospital /ID# 239401 Shenzhen Guangdong China 518025
    68 Henan Cancer Hospital /ID# 215554 Zhengzhou Henan China 450008
    69 Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552 Wuhan Hubei China 430022
    70 Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373 Wuhan Hubei China 430022
    71 Xiangya Hospital Central South University /ID# 219025 Changsha Hunan China 410008
    72 Zhongda Hospital Southeast University /ID# 218926 Nanjing Jiangsu China 210009
    73 The First Affiliated Hospital of Soochow University /ID# 216605 Suzhou Jiangsu China 215006
    74 The Affiliated Hospital of Xuzhou Medical University /ID# 239098 Xuzhou Jiangsu China 221000
    75 The First Affiliated Hospital of Nanchang University /ID# 239168 Nanchang Jiangxi China 330006
    76 Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282 Xi'an Shaanxi China 710038
    77 Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 239317 Shanghai Shanghai China 200065
    78 Shanghai Changhai Hospital /ID# 216334 Shanghai Shanghai China 200433
    79 Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546 Tianjin Tianjin China 300020
    80 The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550 Hangzhou Zhejiang China 310006
    81 Fakultni Nemocnice Brno /ID# 214811 Brno Czechia 625 00
    82 Fakultni nemocnice Hradec Kralove /ID# 214814 Hradec Kralove Czechia 500 05
    83 Fakultni nemocnice Ostrava /ID# 239922 Ostrava Czechia 708 52
    84 Ustav hematologie a krevni transfuze /ID# 215133 Praha Czechia 128 00
    85 CHU de Nice - Hôpital Archet 1 /ID# 214056 Nice Alpes-Maritimes France 06200
    86 CHU de Besancon - Jean Minjoz /ID# 241171 Besancon Doubs France 25030
    87 CHU Bordeaux - Hopital Haut Leveque /ID# 214055 Pessac Gironde France 33604
    88 CHRU Lille - Hopital Claude Huriez /ID# 217916 Lille Hauts-de-France France 59037
    89 CHU de Nantes, Hotel Dieu -HME /ID# 214060 Nantes Pays-de-la-Loire France 44000
    90 AP-HP - Hopital Saint-Louis /ID# 214054 Paris France 75010
    91 AP-HP - Hopital Saint-Antoine /ID# 216957 Paris France 75012
    92 Hopital Pitie Salpetriere /ID# 241072 Paris France 75013
    93 Universitaetsklinik Heidelberg /ID# 216623 Heidelberg Baden-Wuerttemberg Germany 69120
    94 Universitaetsklinikum Muenster /ID# 215213 Muenster Nordrhein-Westfalen Germany 48149
    95 Universitaetsklinikum Leipzig /ID# 245892 Leipzig Sachsen Germany 04103
    96 Klinikum Augsburg /ID# 239583 Augsburg Germany 86156
    97 Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244 Dresden Germany 01307
    98 Universitaetsklinikum Halle (Saale) /ID# 239585 Halle (Saale) Germany 06120
    99 Medizinische Hochschule Hannover /ID# 214243 Hannover Germany 30625
    100 Universitaetsklinikum Wuerzburg /ID# 215212 Wuerzburg Germany 97080
    101 General Hospital of Athens Evangelismos /ID# 238810 Athens Attiki Greece 10676
    102 University General Hospital Attikon /ID# 238812 Athens Attiki Greece 12462
    103 University General Hospital of Patras /ID# 238811 RION Patras Achaia Greece 26504
    104 Debreceni Egyetem Klinikai Kozpont /ID# 241123 Debrecen Hajdu-Bihar Hungary 4032
    105 The Chaim Sheba Medical Center /ID# 214305 Ramat Gan Tel-Aviv Israel 5265601
    106 Tel Aviv Sourasky Medical Center /ID# 214508 Tel Aviv-Yafo Tel-Aviv Israel 6423906
    107 Rambam Health Care Campus /ID# 214507 Haifa Israel 3109601
    108 Hadassah Medical Center-Hebrew University /ID# 218697 Jerusalem Israel 91120
    109 Schneider Children's Medical Center /ID# 224326 Petah Tikva Israel 4920235
    110 Rabin Medical Center /ID# 214509 Petakh Tikva Israel 4941492
    111 Sheba Medical Center /ID# 239571 Tel Hashomer, Ramat Gan Israel 52621
    112 Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910 Rome Lazio Italy 00168
    113 Ospedale San Raffaele IRCCS /ID# 214311 Milan Lombardia Italy 20132
    114 IEO -Istituto Europeo di Oncologia /ID# 242579 Milan Milano Italy 20141
    115 ASST Spedali civili di Brescia /ID# 215997 Brescia Italy 25123
    116 A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148 Turin Italy 10126
    117 Anjou Kousei Hospital /ID# 215857 Anjo-shi Aichi Japan 446-8602
    118 Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679 Nagoya-shi Aichi Japan 453-8511
    119 Kyushu University Hospital /ID# 215285 Fukuoka-shi Fukuoka Japan 812-8582
    120 Hokkaido University Hospital /ID# 215937 Sapporo-shi Hokkaido Japan 060-8648
    121 Kobe City Medical Center General Hospital /ID# 215388 Kobe-shi Hyogo Japan 650-0047
    122 Hyogo College of Medicine College Hospital /Id# 215389 Nishinomiya-shi Hyogo Japan 663-8501
    123 Kanazawa University Hospital /ID# 242955 Kanazawa-shi Ishikawa Japan 920-8641
    124 Imamura General Hospital /ID# 215688 Kagoshima-shi Kagoshima Japan 890-0064
    125 Tokai University Hospital /ID# 250086 Isehara-shi Kanagawa Japan 259-1193
    126 Kanagawa Cancer Center /ID# 215029 Yokohama-shi Kanagawa Japan 241-8515
    127 Kyoto University Hospital /ID# 243209 Kyoto-shi Kyoto Japan 606-8507
    128 Tohoku University Hospital /ID# 214670 Sendai-shi Miyagi Japan 9808574
    129 Okayama University Hospital /ID# 214842 Okayama-shi Okayama Japan 700-8558
    130 Osaka Metropolitan University Hospital /ID# 215227 Osaka-shi Osaka Japan 545-8586
    131 Kindai University Hospital /ID# 214917 Osakasayama-shi Osaka Japan 589-8511
    132 Jichi Medical University Saitama Medical Center /ID# 216092 Saitama-shi Saitama Japan 330-8503
    133 Jichi Medical University Hospital /ID# 216091 Shimotsuke-shi Tochigi Japan 329-0498
    134 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939 Bunkyo-ku Tokyo Japan 113-8677
    135 National Cancer Center Hospital /ID# 242639 Chuo-ku Tokyo Japan 104-0045
    136 Toranomon Hospital /ID# 215311 Minato-ku Tokyo Japan 105-8470
    137 National Center for Child Health and Development /ID# 242479 Setagaya-ku Tokyo Japan 157-8535
    138 Keio University Hospital /ID# 243549 Shinjuku-ku Tokyo Japan 160-8582
    139 Seoul National University Hospital /ID# 214891 Seoul Korea, Republic of 03080
    140 Asan Medical Center /ID# 214893 Seoul Korea, Republic of 05505
    141 Samsung Medical Center /ID# 239087 Seoul Korea, Republic of 06351
    142 The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892 Seoul Korea, Republic of 06591
    143 Rogachev Nat Med Research Ctr for Pediatric Hematology, Onc /ID# 216538 Moscow Moskva Russian Federation 117198
    144 Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 214609 St. Petersburg Sankt-Peterburg Russian Federation 197101
    145 Kirov Research Institute of Hematology and Blood Transfusion of FMBA /ID# 216591 Kirov Russian Federation 610027
    146 Clinic of Immunopathology, SRIFCI /ID# 215201 Novosibirsk Russian Federation 630047
    147 Almazov National Medical Research Centre /ID# 214357 Sankt-Peterburg Russian Federation 197341
    148 Hospital Clinic de Barcelona /ID# 215108 Barcelona Spain 08036
    149 Hospital Santa Creu i Sant Pau /ID# 240397 Barcelona Spain 08041
    150 Hospital General Universitario Gregorio Maranon /ID# 215107 Madrid Spain 28007
    151 Hospital Universitario Ramon y Cajal /ID# 218102 Madrid Spain 28034
    152 Hospital Universitario La Paz /ID# 218103 Madrid Spain 28046
    153 Hospital Universitario Virgen del Rocio /ID# 215463 Sevilla Spain 41013
    154 Hospital Clinico Universitario de Valencia /ID# 215106 Valencia Spain 46010
    155 Universitätsspital Basel /ID# 215892 Basel Basel-Stadt Switzerland 4031
    156 Universitatsspital Zurich /ID# 215891 Zurich Zuerich Switzerland 8091
    157 Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197 Kaohsiung Taiwan 807
    158 China Medical University Hospital /ID# 215198 Taichung City Taiwan 40447
    159 Taichung Veterans General Hospital /ID# 239288 Taichung Taiwan 40705
    160 National Taiwan University Hospital /ID# 215245 Taipei City Taiwan 100
    161 Taipei Veterans General Hosp /ID# 239289 Taipei City Taiwan 11217
    162 Linkou Chang Gung Memorial Hospital /ID# 215319 Taoyuan City Taiwan 333
    163 University Hospital Southampton NHS Foundation Trust /ID# 244849 Southampton Hampshire United Kingdom SO16 6YD
    164 NHS Greater Glasgow and Clyde /ID# 215663 Glasgow Scotland United Kingdom G12 0XH
    165 University Hospitals Birmingham NHS Foundation Trust /ID# 215120 Birmingham United Kingdom B15 2TH
    166 University College London Hospitals NHS Foundation Trust /ID# 215662 London United Kingdom NW1 2PG
    167 King's College Hospital NHS Foundation Trust /ID# 215338 London United Kingdom SE5 9RS
    168 The Royal Marsden NHS Foundation Trust /ID# 215124 London United Kingdom SW3 6JJ
    169 Imperial College Healthcare NHS Trust /ID# 215665 London United Kingdom W2 1NY
    170 The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359 Newcastle Upon Tyne United Kingdom NE7 7DN

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04161885
    Other Study ID Numbers:
    • M19-063
    • 2019-002621-30
    First Posted:
    Nov 13, 2019
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Acute Myeloid Leukemia (AML)
    Venetoclax
    Azacitidine
    Stem Cell Transplantation (SCT)
    Best Support Care (BSC)
    Cancer
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Azacitidine
    Venetoclax

    Study Results

    No Results Posted as of Aug 25, 2022