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A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival (VIALE-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102020
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Venetoclax Drug: Azacitidine Other: Best Supportive Care (BSC) Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : October 7, 2024
Estimated Study Completion Date : August 11, 2025


Arm Intervention/treatment
Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive care
Participants will be administered with venetoclax dose A once daily (QD) (Days 1-28) up to 24 cycles, azacitidine (AZA) dose A QD on Days 1-5 of each 28 day cycle 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

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

Other: Best Supportive Care (BSC)
BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.

Experimental: Part 2: Arm A: Venetoclax + Azacitidine (AZA) + BSC
Participants will be administered with venetoclax dose A QD (Days 1-28) up to 24 cycles, azacitidine (AZA) dose A, on Days 1-5 of each 28-day cycle 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

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

Other: Best Supportive Care (BSC)
BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.

Experimental: Part 2: Arm B: Best Supportive Care (BSC)
Participants will receive treatment as prescribed by their physician according to the best supportive care for up to 24 cycles (1 cycle = 28 days)
Other: Best Supportive Care (BSC)
BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.




Primary Outcome Measures :
  1. Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1) [ Time Frame: 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.

  2. Relapse-Free Survival (RFS) (Part 2) [ Time Frame: Time from treatment to relapse or death from any cause, up to approximately 3 years ]
    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) [ Time Frame: Time from treatment to death from any cause, up to approximately 3 years ]
    OS is defined as the number of days from the date of randomization to the date of death.

  2. Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) [ Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized ]
    The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.

  3. Time to Deterioration in Global Health Status (GHS)/Quality-of Life (QoL) Score Based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30-Item (EORTC QLQ-C30) Scoring Manual. [ Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized ]
    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."

  4. Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a [ Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized ]
    Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 planned induction and consolidation chemotherapy.
    • Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy.
    • AML has intermediate or adverse 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102020


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Alabama
University of Alabama at Birmingham - Main /ID# 214523 Not yet recruiting
Birmingham, Alabama, United States, 35233
Mitchell Cancer Institute /ID# 216443 Not yet recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
University of Arkansas for Medical Sciences /ID# 218105 Not yet recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156 Not yet recruiting
Fountain Valley, California, United States, 92708-7501
UCSD Moores Cancer Center - LaJolla /ID# 216065 Not yet recruiting
La Jolla, California, United States, 92093
United States, Colorado
Colorado Blood Cancer Institute /ID# 214280 Not yet recruiting
Denver, Colorado, United States, 80218
United States, Idaho
St. Alphonsus Regional Medical /ID# 216424 Not yet recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Rush University Medical Center /ID# 218815 Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky Markey Cancer Center /ID# 215048 Not yet recruiting
Lexington, Kentucky, United States, 40536-7001
Norton Cancer Institute /ID# 216401 Not yet recruiting
Louisville, Kentucky, United States, 40202-3700
United States, Louisiana
Tulane Medical Center - New Orleans /ID# 218166 Not yet recruiting
New Orleans, Louisiana, United States, 70112-2600
Ochsner Clinic Foundation-New Orleans /ID# 214583 Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Tufts Medical Center /ID# 216110 Not yet recruiting
Boston, Massachusetts, United States, 02111
Mass General Hospital /ID# 217307 Not yet recruiting
Boston, Massachusetts, United States, 02114-4724
United States, Michigan
Univ Michigan Med Ctr /ID# 216524 Not yet recruiting
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
Univ of Mississippi Med Ctr /ID# 216475 Not yet recruiting
Jackson, Mississippi, United States, 39216-4500
United States, Missouri
University of Missouri /ID# 218223 Not yet recruiting
Columbia, Missouri, United States, 65212
Oncology Hematology Associates (OHA) - Springfield /ID# 216351 Not yet recruiting
Springfield, Missouri, United States, 65807-5287
United States, New Jersey
The John Theurer Cancer /ID# 215191 Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Univ Rochester Med Ctr /ID# 215881 Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina /ID# 215815 Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Oregon
Providence Portland Medical Ct /ID# 216231 Not yet recruiting
Portland, Oregon, United States, 97213-2933
United States, Pennsylvania
UPMC Hillman Cancer Ctr /ID# 214051 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Prisma Health /ID# 216066 Not yet recruiting
Greenville, South Carolina, United States, 29605-4255
St Francis Cancer Center (Bon Secours) /ID# 216115 Not yet recruiting
Greenville, South Carolina, United States, 29607-5253
Gibbs Cancer Center & Research /ID# 216192 Not yet recruiting
Spartanburg, South Carolina, United States, 29303-3040
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 215250 Not yet recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584 Not yet recruiting
Dallas, Texas, United States, 75246-2003
Australia, New South Wales
St George Hospital /ID# 215416 Not yet recruiting
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital /ID# 215415 Not yet recruiting
Liverpool, New South Wales, Australia, 2170
Wollongong Hospital /ID# 216071 Not yet recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Gold Coast University Hospital /ID# 214650 Not yet recruiting
Southport, Queensland, Australia, 4215
Australia, Victoria
Barwon Health University Hospital Geelong /ID# 217921 Not yet recruiting
Geelong, Victoria, Australia, 3220
Box Hill Hospital /ID# 217622 Not yet recruiting
Melbourne, Victoria, Australia, 3128
Australia, Western Australia
Perth Blood Institute Ltd /ID# 217531 Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Australia
Toowoomba Hospital /ID# 217922 Not yet recruiting
Toowoomba, Australia, 4350
Brazil
Hospital São Rafael /ID# 215233 Not yet recruiting
Salvador, Bahia, Brazil, 41253-190
Hospital de Clinicas de Porto Alegre /ID# 215044 Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215234 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 215171 Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Canada, Alberta
Tom Baker Cancer Centre /ID# 214625 Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
University of Alberta Hospital /ID# 215656 Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G3
Canada, Ontario
Juravinski Hosp & Cancer Cntr /ID# 214623 Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Ctr /ID# 216055 Not yet recruiting
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital /ID# 214627 Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre /ID# 214624 Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
China, Beijing
Peking University Peoples Hospital /ID# 216331 Not yet recruiting
Beijing, Beijing, China, 100044
China, Fujian
Fujian Medical Univ Union Hosp /ID# 215561 Not yet recruiting
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong Provincial People's Hospital /ID# 216284 Not yet recruiting
Guangzhou, Guangdong, China, 510080
Nanfang Hospital of Southern Medical University /ID# 215565 Not yet recruiting
Guangzhou, Guangdong, China, 510515
China, Jilin
The First Hosp of Jilin Univ /ID# 215560 Not yet recruiting
Changchun, Jilin, China, 130021
China, Liaoning
First Hospital of China Medical University /ID# 216285 Not yet recruiting
Shenyang, Liaoning, China, 110001
China, Sichuan
West China Hospital /ID# 216606 Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Tianjin
Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 215558 Not yet recruiting
Tianjin, Tianjin, China, 300020
China, Zhejiang
The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 215564 Not yet recruiting
Hangzhou, Zhejiang, China, 310003
China
Beijing Friendship Hospital /ID# 216455 Not yet recruiting
Beijing, China, 100050
Peking Union Medical College H /ID# 216454 Not yet recruiting
Beijing, China, 100730
Chinese PLA General Hospital /ID# 216286 Not yet recruiting
Beijing, China, 100853
Peking University International Hospital /ID# 217439 Not yet recruiting
Beijing, China, 102206
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046 Not yet recruiting
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 216456 Not yet recruiting
Wuhan, China, 430030
Henan Cancer Hospital /ID# 215566 Not yet recruiting
Zhengzhou Henan, China, 450008
Czechia
Fakultni nemocnice Ostrava /ID# 214809 Not yet recruiting
Ostrava, Praha 5, Czechia, 708 52
Fakultni Nemocnice Brno /ID# 214807 Not yet recruiting
Brno, Czechia, 625 00
Ustav Hematologie a krevni transfuze /ID# 215137 Not yet recruiting
Prague 28, Czechia, 128 00
France
CHRU Lille - Hôpital Claude Huriez /ID# 217474 Not yet recruiting
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Bretonneau - CHU Tours /ID# 216186 Not yet recruiting
Tours CEDEX 9, Indre-et-Loire, France, 37044
Centre Hospitalier Le Mans /ID# 215148 Not yet recruiting
Le Mans CEDEX 9, Sarthe, France, 72037
Institut Gustave Roussy /ID# 215158 Not yet recruiting
Villejuif, Val-de-Marne, France, 94800
CHU d'Angers /ID# 215151 Not yet recruiting
Angers, France, 49933
Centre Hospitalier de la Cote /ID# 216185 Not yet recruiting
Bayonne, France, 64100
CHU Henri Mondor /ID# 215159 Not yet recruiting
Creteil, France, 94000
Hopital Andre Mignot /ID# 215157 Not yet recruiting
Le Chesnay, France, 78150
CHU de Nantes, Hotel Dieu -HME /ID# 217367 Not yet recruiting
Nantes, France, 44093
CHU de Nice /ID# 217368 Not yet recruiting
Nice, France, 06202
CHU Bordeaux /ID# 215150 Not yet recruiting
Pessac, France, 33600
Germany
Universitaetsklinikum Leipzig /ID# 214440 Not yet recruiting
Leipzig, Sachsen, Germany, 04103
Klinikum Chemnitz gGmbH /ID# 216073 Not yet recruiting
Chemnitz, Germany, 09116
Universitaetsklinikum Schleswig-Holstein /ID# 215173 Not yet recruiting
Lübeck, Germany, 23538
Uniklinikum Giessen-Marburg Gm /ID# 214734 Not yet recruiting
Marburg, Germany, 35043
Krankenhaus Barmherzige Bruede /ID# 215170 Not yet recruiting
Regensburg, Germany, 93049
Greece
General Hospital of Athens Laiko /ID# 213869 Not yet recruiting
Athens, Attiki, Greece, 115 27
University General Hospital Attikon /ID# 214298 Not yet recruiting
Athens, Attiki, Greece, 12462
Gen Univ Hosp Alexandroupolis /ID# 213870 Not yet recruiting
Alexandroupolis, Greece, 68100
Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 213872 Not yet recruiting
Athens, Greece, 10676
University General Hospital of Heraklion "PA.G.N.I" /ID# 214075 Not yet recruiting
Heraklion, Greece, 71110
Patras University General Hosp /ID# 213871 Not yet recruiting
Rion, Patras, Achaia, Greece, 26504
Hungary
Markusovszky Egyetemi Oktatokorhaz /ID# 215644 Not yet recruiting
Szombathely, Vas, Hungary, 9700
Semmelweis Egyeteme III /ID# 214423 Not yet recruiting
Budapest, Hungary, 1125
Debreceni Egyetem Klinikai Központ /ID# 214422 Not yet recruiting
Debrecen, Hungary, 4032
Kaposi Mor Oktato Korhaz /ID# 214426 Not yet recruiting
Kaposvar, Hungary, 7400
Szabolcs-Szatmar-Beregi /ID# 214425 Not yet recruiting
Nyíregyhaza, Hungary, 4400
Italy
AOU Federico II /ID# 214278 Not yet recruiting
Naples, Campania, Italy, 80131
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946 Not yet recruiting
Milano, Lombardia, Italy, 20162
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 214826 Not yet recruiting
Milan, Lombardia, Italy, 20122
AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 213944 Not yet recruiting
Ancona, Marche, Italy, 60126
AOU Citta della Salute Scienza /ID# 214505 Not yet recruiting
Turin, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi /ID# 213948 Not yet recruiting
Bologna, Italy, 40138
A.O. Spedali Civili Brescia /ID# 214580 Not yet recruiting
Brescia, Italy, 25123
Azienda Ospedaliero Universita /ID# 214802 Not yet recruiting
Catania, Italy, 95123
AORN A. Cardarelli /ID# 213947 Not yet recruiting
Napoli, Italy, 80131
Ospedale S.Eugenio /ID# 214277 Not yet recruiting
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital /ID# 215284 Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
University of Fukui Hospital /ID# 215283 Recruiting
Yoshida-gun, Fukui, Japan, 910-1193
National Hospital Organization Kyushu Cancer Center /ID# 214841 Not yet recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Kyushu University Hospital /ID# 215286 Not yet recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
National Hospital Organization Mito Medical Center /ID# 214699 Not yet recruiting
Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
Hitachi General Hospital /ID# 214707 Not yet recruiting
Hitachi-shi, Ibaraki, Japan, 317-0077
Tohoku University Hospital /ID# 214669 Not yet recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Nagasaki University Hospital /ID# 214916 Not yet recruiting
Nagasaki-shi, Nagasaki, Japan, 852-8501
Okayama University Hospital /ID# 214840 Recruiting
Okayama-shi, Okayama, Japan, 700-8558
Kindai University Hospital /ID# 214915 Not yet recruiting
Osaka-sayama, Osaka, Japan, 5898511
Osaka City University Hospital /ID# 215225 Recruiting
Osaka-shi, Osaka, Japan, 545-0051
Saitama Medical University International Medical Center /ID# 214823 Recruiting
Hidaka-shi, Saitama, Japan, 350-1298
Jichi Medical University Hospital /ID# 216812 Not yet recruiting
Shimotsuke-shi, Tochigi, Japan, 329-0498
NTT Medical Center Tokyo /ID# 214959 Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Yamagata University Hospital /ID# 214698 Not yet recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
JP Red Cross Nagoya Daiichi /ID# 215680 Recruiting
Nagoya, Japan, 453-8511
Hokkaido University Hospital /ID# 215938 Recruiting
Sapporo, Japan, 060-8648
Korea, Republic of
Pusan National University Hosp /ID# 213941 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49241
Seoul National Univ Bundang ho /ID# 215549 Not yet recruiting
Seongnam, Gyeonggido, Korea, Republic of, 13620
Samsung Medical Center /ID# 213940 Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Seoul National University Hospital /ID# 213943 Not yet recruiting
Seoul, Korea, Republic of, 03080
Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 214953 Not yet recruiting
Rio Piedras, Puerto Rico, 00935
Russian Federation
Moscow State budget healthcare /ID# 214312 Not yet recruiting
Moscow, Moskva, Russian Federation, 125284
Nizhniy Novgorod Region clinical hospital named N. A. Semashko /ID# 214309 Not yet recruiting
Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 214315 Not yet recruiting
Saratov, Saratovskaya Oblast, Russian Federation, 410012
City Clinical Hospital №40 /ID# 215223 Not yet recruiting
Moscow, Russian Federation, 129301
Clinic of immunopathology under SRIFCI /ID# 217937 Not yet recruiting
Novosibirsk, Russian Federation, 630047
Almazov North-West Federal Med /ID# 214306 Not yet recruiting
Sankt-peterburg, Russian Federation, 197341
GUZ of Yaroslavl region Yaroslavl Regional Clinical Hospital /ID# 214318 Not yet recruiting
Yaroslavl, Russian Federation, 150062
Spain
Hospital Santa Creu i Sant Pau /ID# 214714 Not yet recruiting
Barcelona, Spain, 08026
ICO l´Hosp- Hosp Duran Reynals /ID# 214715 Not yet recruiting
Barcelona, Spain, 08907
Hospital Reina Sofia de Cordob /ID# 214786 Not yet recruiting
Cordoba, Spain, 14004
Hospital Universitario Infanta Leonor /ID# 214843 Not yet recruiting
Madrid, Spain, 28031
MD Anderson CC Madrid /ID# 214477 Not yet recruiting
Madrid, Spain, 28033
Hospital Ramon y Cajal /ID# 214684 Not yet recruiting
Madrid, Spain, 28036
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933 Not yet recruiting
Madrid, Spain, 28040
Hospital 12 de Octubre /ID# 214789 Not yet recruiting
Madrid, Spain, 28041
Hosp Uni Virgen de la Victoria /ID# 214713 Not yet recruiting
Malaga, Spain, 29010
Complejo Hospitalario de Navar /ID# 214788 Not yet recruiting
Pamplona, Spain, 31008
Taiwan
China Medical University Hosp /ID# 213952 Not yet recruiting
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 213939 Not yet recruiting
Taipei City, Taipei, Taiwan, 10002
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953 Recruiting
Kaohsiung, Taiwan, 80708
Linkou Chang Gung Memorial Ho /ID# 213951 Not yet recruiting
Taoyuan City, Taiwan, 33305
Turkey
Erciyes University Medical Fac /ID# 214240 Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Gulhane Askeri Tip Academy /ID# 214242 Not yet recruiting
Ankara, Turkey, 06010
Ankara Univ Medical Faculty /ID# 214239 Not yet recruiting
Ankara, Turkey, 06590
Istanbul University Cerrahpasa Medical Faculty /ID# 215525 Not yet recruiting
Istanbul, Turkey, 34098
Karadeniz University /ID# 214241 Not yet recruiting
Trabzon, Turkey, 61000
United Kingdom
Leicester Royal Infirmary /ID# 215924 Not yet recruiting
Leicester, England, United Kingdom, LE1 5WW
Belfast City Hospital /ID# 215923 Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Heart of England NHS Foundation Trust /ID# 215910 Not yet recruiting
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Onc Ct /ID# 215911 Not yet recruiting
Bristol, United Kingdom, BS2 8ED
University Hospital of Wales /ID# 215906 Not yet recruiting
Cardiff, United Kingdom, CF14 4EN
St. James University Hospital /ID# 215922 Not yet recruiting
Leeds, United Kingdom, LS9 7TF
St Bartholomew's Hospital, Bar /ID# 215909 Not yet recruiting
London, United Kingdom, EC1A 7BE
UCLH, University College Hospi /ID# 215921 Not yet recruiting
London, United Kingdom, NW1 2PG
Guy's Hospital /ID# 215908 Not yet recruiting
London, United Kingdom, SE1 9RT
Christie NHS Foundation Trust /ID# 215905 Not yet recruiting
Manchester, United Kingdom, M20 4BX
Nottingham Univ Hospitals NHS /ID# 215904 Not yet recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
AbbVie
Roche-Genentech
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04102020    
Other Study ID Numbers: M19-708
2019-002217-19 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Venetoclax
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors