Acute Myeloid Leukemia (AML)Phase 3VIALE-TNCT04161885
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)
A Phase 3 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML) and Cancer, run by AbbVie at 165 sites in 18 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Cancer
- What is being tested?
- Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 165 sitesin 18 countries
- Study dates
- 26 Feb 2020to 23 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
165 sites in 18 countries.
165 sites in 18 countries
United States43 sites
UCHSC Anschultz Cancer Pavilion /ID# 215618
Aurora, Colorado, 80045-2517
University of Maryland, Baltimore /ID# 213855
Baltimore, Maryland, 21201
Massachusetts General Hospital /ID# 215765
Boston, Massachusetts, 02114
Roswell Park Cancer Institute /ID# 217857
Buffalo, New York, 14263
University of North Carolina /ID# 215814
Chapel Hill, North Carolina, 27514
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 215840
Chicago, Illinois, 60611
The University of Chicago Medical Center /ID# 215616
Chicago, Illinois, 60637-1443
UC Health - Cincinnati /ID# 239263
Cincinnati, Ohio, 45267-2800
University Hospitals Cleveland Medical Center /ID# 239260
Cleveland, Ohio, 44106
Texas Oncology - Medical City Dallas /ID# 216720
Dallas, Texas, 75230
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
Dallas, Texas, 75246-2003
Colorado Blood Cancer Institute /ID# 215980
Denver, Colorado, 80218
Karmanos Cancer Institute - Dresner Clinic /ID# 214581
Detroit, Michigan, 48201-2013
City of Hope /ID# 213681
Duarte, California, 91010
The John Theurer Cancer /ID# 215251
Hackensack, New Jersey, 07601
Penn State Hershey Medical Ctr /ID# 217120
Hershey, Pennsylvania, 17033-2360
Indiana Blood & Marrow Transpl /ID# 215842
Indianapolis, Indiana, 46237
University of Mississippi Medical Center /ID# 239343
Jackson, Mississippi, 39216-4500
Mayo Clinic Hospital Jacksonville /ID# 239710
Jacksonville, Florida, 32224
University of Arkansas for Medical Sciences /ID# 239804
Little Rock, Arkansas, 72205
Univ of Wisconsin Hosp/Clinics /ID# 216096
Madison, Wisconsin, 53792-0001
Loyola University Medical Ctr /ID# 215617
Maywood, Illinois, 60153
Masonic Cancer Center /ID# 239492
Minneapolis, Minnesota, 55455
TriStar Centennial Medical Center /ID# 218750
Nashville, Tennessee, 37203-1551
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834
New Orleans, Louisiana, 70121
Columbia University Medical Center /ID# 240875
New York, New York, 10032-3729
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680
New York, New York, 10065-6007
Weill Cornell Medical College /ID# 214887
New York, New York, 10065
University of Oklahoma, Stephenson Cancer Center /ID# 215611
Oklahoma City, Oklahoma, 73104-5418
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
Orlando, Florida, 32804-5505
Children's Hospital of Philadelphia - Main /ID# 215410
Philadelphia, Pennsylvania, 19104-4319
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 214518
Philadelphia, Pennsylvania, 19104
Duplicate_Allegheny General Hospital /ID# 216756
Pittsburgh, Pennsylvania, 15212
UPMC Hillman Cancer Ctr /ID# 213715
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University /ID# 215874
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center Main Hospital /ID# 239203
Richmond, Virginia, 23219
Mayo Clinic - Rochester /ID# 214685
Rochester, Minnesota, 55905-0001
Texas Transplant Institute /ID# 214691
San Antonio, Texas, 78229
Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711
Scottsdale, Arizona, 85258-4547
Fred Hutchinson Cancer Research Center /ID# 214436
Seattle, Washington, 98109-1024
Montefiore Medical Center - Moses Campus /ID# 241669
The Bronx, New York, 10467
University of Arizona Cancer Center - Tucson /ID# 242507
Tucson, Arizona, 85724
Atrium Health Wake Forest Baptist Medical Center /ID# 239210
Winston-Salem, North Carolina, 27157
Japan26 sites
Anjou Kousei Hospital /ID# 215857
Anjo-shi, Aichi-ken, 446-8602
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
Bunkyo-ku, Tokyo, 113-8677
National Cancer Center Hospital /ID# 242639
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital /ID# 215285
Fukuoka, Fukuoka, 812-8582
Fukushima Medical University Hospital /ID# 252293
Fukushima, Fukushima, 960-1295
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
Hiroshima, Hiroshima, 730-8619
Tokai University Hospital /ID# 250086
Isehara, Kanagawa, 259-1193
Imamura General Hospital /ID# 215688
Kagoshima, Kagoshima-ken, 890-0064
Kanazawa University Hospital /ID# 242955
Kanazawa, Ishikawa-ken, 920-8641
Kobe City Medical Center General Hospital /ID# 215388
Kobe, Hyōgo, 650-0047
Kyoto University Hospital /ID# 243209
Kyoto, Kyoto, 606-8507
Toranomon Hospital /ID# 215311
Minato-ku, Tokyo, 105-8470
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
Nagoya, Aichi-ken, 453-8511
Hyogo Medical University Hospital /ID# 215389
Nishinomiya-shi, Hyōgo, 663-8501
Okayama University Hospital /ID# 214842
Okayama, Okayama-ken, 700-8558
Osaka Metropolitan University Hospital /ID# 215227
Osaka, Osaka, 545-8586
Jichi Medical University Saitama Medical Center /ID# 216092
Saitama-shi, Saitama, 330-8503
Kindai University Hospital /ID# 214917
Sakai-shi, Osaka, 590-0197
Hokkaido University Hospital /ID# 215937
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital /ID# 214670
Sendai, Miyagi, 9808574
Duplicate_National Center for Child Health and Development /ID# 242479
Setagaya-ku, Tokyo, 157-8535
Jichi Medical University Hospital /ID# 216091
Shimotsuke-shi, Tochigi, 329-0498
Keio University Hospital /ID# 243549
Shinjuku-ku, Tokyo, 160-8582
Yamagata University Hospital /ID# 253304
Yamagata, Yamagata, 990-9585
Kanagawa Cancer Center /ID# 215029
Yokohama, Kanagawa, 241-8515
University of Fukui Hospital /ID# 253383
Yoshida-gun, Fukui, 910-1104
China20 sites
Peking University People's Hospital /ID# 215551
Beijing, Beijing Municipality, 100044
Chinese PLA General Hospital /ID# 216287
Beijing, Beijing Municipality, 100853
Aerospace Center Hospital /ID# 217018
Beijing, Beijing Municipality, 861059
Xiangya Hospital Central South University /ID# 219025
Changsha, Hunan, 410008
Fujian Medical University Union Hospital /ID# 215555
Fuzhou, Fujian, 350001
Guangdong Provincial Peoples Hospital /ID# 218666
Guangzhou, Guangdong, 510080
Zhujiang Hospital of Southern Medical University /ID# 216333
Guangzhou, Guangdong, 510280
Nanfang Hospital of Southern Medical University /ID# 215553
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital of Nanchang University /ID# 239168
Nanchang, Jiangxi, 330006
Zhongda Hospital Southeast University /ID# 218926
Nanjing, Jiangsu, 210009
Shanghai Changhai Hospital /ID# 216334
Shanghai, Shanghai Municipality, 200433
Shenzhen Second Peoples Hospital /ID# 239401
Shenzhen, Guangdong, 518039
The First Affiliated Hospital of Soochow University /ID# 216605
Suzhou, Jiangsu, 215006
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
Tianjin, Tianjin Municipality, 300020
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
Wuhan, Hubei, 430022
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373
Wuhan, Hubei, 430022
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282
Xi’an, Shanxi, 710038
The Affiliated Hospital of Xuzhou Medical College /ID# 239098
Xuzhou, Jiangsu, 221006
Henan Cancer Hospital /ID# 215554
Zhengzhou, Henan, 450008
France8 sites
Duplicate_CHU de Besancon - Jean Minjoz /ID# 241171
Besançon, Doubs, 25030
CHRU Lille - Hopital Claude Huriez /ID# 217916
Lille, Nord, 59037
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 214060
Nantes, Pays de la Loire Region, 44000
Duplicate_CHU de Nice - Hôpital Archet 1 /ID# 214056
Nice, Alpes-Maritimes, 06200
Hôpital Saint-Louis /ID# 214054
Paris, 75010
AP-HP - Hopital Saint-Antoine /ID# 216957
Paris, 75012
Hopital Pitie Salpetriere /ID# 241072
Paris, Île-de-France Region, 75013
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 214055
Pessac, Gironde, 33604
Germany8 sites
Klinikum Augsburg /ID# 239583
Augsburg, Bavaria, 86156
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 214244
Dresden, Saxony, 01307
Universitaetsklinikum Halle (Saale) /ID# 239585
Halle, 06120
Medizinische Hochschule Hannover /ID# 214243
Hanover, Lower Saxony, 30625
Universitaetsklinik Heidelberg /ID# 216623
Heidelberg, Baden-Wurttemberg, 69120
Universitaetsklinikum Leipzig /ID# 245892
Leipzig, Saxony, 04103
Universitaetsklinikum Muenster /ID# 215213
Münster, North Rhine-Westphalia, 48149
Duplicate_Universitaetsklinikum Wuerzburg /ID# 215212
Würzburg, Bavaria, 97080
Israel7 sites
Rambam Health Care Campus /ID# 214507
Haifa, 3109601
Hadassah Medical Center-Hebrew University /ID# 218697
Jerusalem, Jerusalem, 91120
Schneider Children's Medical Center /ID# 224326
Petah Tikva, Central District, 4920235
Rabin Medical Center. /ID# 214509
Petah Tikva, 4941492
Sheba Medical Center /ID# 239571
Ramat Gan, Tel Aviv, 52621
The Chaim Sheba Medical Center /ID# 214305
Ramat Gan, Tel Aviv, 5265601
Tel Aviv Sourasky Medical Center /ID# 214508
Tel Aviv, Tel Aviv, 6423906
Spain7 sites
Hospital Clinic de Barcelona /ID# 215108
Barcelona, 08036
Hospital Santa Creu i Sant Pau /ID# 240397
Barcelona, 08041
Hospital General Universitario Gregorio Maranon /ID# 215107
Madrid, 28007
Hospital Universitario Ramon y Cajal /ID# 218102
Madrid, 28034
Hospital Universitario La Paz /ID# 218103
Madrid, 28046
Hospital Universitario Virgen del Rocio /ID# 215463
Seville, 41013
Hospital Clinico Universitario de Valencia /ID# 215106
Valencia, 46010
United Kingdom7 sites
University Hospitals Birmingham NHS Foundation Trust /ID# 215120
Birmingham, B15 2TH
Gartnavel General Hospital /ID# 215663
Glasgow, Glasgow City, G12 0YN
Hammersmith Hospital /ID# 215665
London, England, W12 0HS
University College London Hospital /ID# 215662
London, Greater London, NW1 2BU
Kings College Hospital NHS Foundation Trust /ID# 215338
London, Greater London, SE5 9RS
The Royal Marsden NHS Foundation Trust /ID# 215124
London, SW3 6JJ
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
Newcastle upon Tyne, NE3 3HD
Italy6 sites
ASST degli Spedali Civili di Brescia /ID# 215997
Brescia, 25123
IRCCS Ospedale San Raffaele /ID# 214311
Milan, Milano, 20132
Istituto Europeo Di Oncologia /ID# 242579
Milan, Milano, 20141
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
Rome, Roma, 00161
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 214910
Rome, Roma, 00168
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 216148
Turin, Piedmont, 10126
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
Kaohsiung City, 807
China Medical University Hospital /ID# 215198
Taichung, 40447
Taichung Veterans General Hospital /ID# 239288
Taichung, 40705
Taipei Veterans General Hosp /ID# 239289
Taipei, 11217
National Taiwan University Hospital /ID# 215245
Taipei City, Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 215319
Taoyuan City, 333
Canada5 sites
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
Montreal, Quebec, H1T 2M4
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 215253
Montreal, Quebec, H4A 3J1
Saskatoon Cancer Centre /ID# 238821
Saskatoon, Saskatchewan, S7N 4H4
University Health Network_Princess Margaret Cancer Centre /ID# 215344
Toronto, Ontario, M5G 2M9
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
Vancouver, British Columbia, V5Z 1M9
Australia4 sites
Royal Adelaide Hospital /ID# 215678
Adelaide, South Australia, 5000
The Kinghorn Cancer Centre /ID# 214660
Darlinghurst, New South Wales, 2010
Peter MacCallum Cancer Ctr /ID# 214653
Melbourne, Victoria, 3000
The Alfred Hospital /ID# 240931
Melbourne, Victoria, 3004
Brazil4 sites
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
Jaú, São Paulo, 17210-070
Hospital de Clinicas de Porto Alegre /ID# 215042
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital Nove de Julho /ID# 242359
São Paulo, São Paulo, 01409-001
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 239516
São Paulo, 05403-000
Czechia4 sites
Fakultní Nemocnice Brno - Jihlavská /ID# 214811
Brno, Brno-mesto, 625 00
Fakultní nemocnice Hradec Králové - Sokolská /ID# 214814
Hradec Králové, Hradec Kralove, 500 05
Fakultni Nemocnice Ostrava /ID# 239922
Ostrava, Ostrava-mesto, 708 52
Ustav hematologie a krevni transfuze /ID# 215133
Prague, 128 00
South Korea4 sites
Seoul National University Hospital /ID# 214891
Seoul, Seoul Teugbyeolsi, 03080
Asan Medical Center /ID# 214893
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 239087
Seoul, Seoul Teugbyeolsi, 06351
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892
Seoul, Seoul Teugbyeolsi, 06591
Greece3 sites
General Hospital of Athens Evangelismos /ID# 238810
Athens, Attica, 10676
University General Hospital Attikon /ID# 238812
Athens, Attica, 12462
University General Hospital of Patras /ID# 238811
RION Patras Achaia, 26504
Switzerland2 sites
Duplicate_Universitätsspital Basel /ID# 215892
Basel, Canton of Basel-City, 4031
University Hospital Zurich /ID# 215891
Zurich, Canton of Zurich, 8091
Hungary1 site
Debreceni Egyetem-Klinikai Kozpont /ID# 241123
Debrecen, Hajdú-Bihar, 4032
About this study
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)
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
- Being tested
- Venetoclax, Azacitidine, Best Supportive Care (BSC)
- Keywords
- Acute Myeloid Leukemia (AML), Venetoclax, Azacitidine, Stem Cell Transplantation (SCT), Best Support Care (BSC), Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199, VENCLEXTA
Tablet; Oral
AzacitidineDrug
Subcutaneous (SC) or intravenous (IV) injection
Best Supportive Care (BSC)Other
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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). Receives: Drug: Venetoclax; Drug: Azacitidine; Other: Best Supportive Care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
DLTs were 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.
Measured: Up to 28 days
Overall Survival (OS) (Part 2)
OS was defined as the time from the date of randomization to the date of death from any cause.
Measured: Up to approximately 41 months
Secondary outcomes (9)
Morphologic Relapse-Free Survival (RFS) (Part 2)
Morphologic relapse from AML was defined as bone marrow blasts of >= 5% or reappearance of blasts in the peripheral blood not attributable to any other cause (e.g., bone marrow regeneration) in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease after achieving a complete remission (CR) or complete remission with incomplete count recovery (CRi); or the date of death from any cause, whichever comes first as determined by the investigator.
Measured: Up to approximately 41 months
Composite Relapse-Free Survival (RFS) (Part 2)
Composite RFS was defined as the time from randomization from either morphologic relapse from AML, or non-morphologic relapse from AML, whichever comes first. Non-morphologic relapse from AML was defined as increase in disease burden determined by standard methods with reappearance or acquisition of new findings with or without change in anti-leukemic treatment per investigator decision due to cytogenetic abnormalities or change in molecular marker or measurable residual disease by multiparameter flow with sensitivity to at least 10^-3; or the date of death from any cause, whichever came first as determined by the investigator.
Measured: Up to approximately 41 months
Graft-versus-Host Disease (GvHD)-Free, Relapse Free Survival (GRFS) (Part 2)
GRFS was defined as the time from the date of randomization to occurrence of disease relapse or incidence of GvHD or death from any cause.
Measured: Up to approximately 41 months
Rate of Participants Without Higher Grade of GvHD (Part 2)
Rate of Participants without higher grade of GvHD was defined as the percentage of participants without grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator at 90 days after randomization.
Measured: 90 days after randomization
Change From Baseline in Physical Functioning Subscore as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)
The EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales. The physical functioning score, reported here, ranged from 0 to 100, with a higher score indicating a better level of functioning. Positive changes from baseline indicate improvement.
Measured: Baseline, Month 6
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a Score (Part 2)
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Measured: Baseline, Month 6
Percentage of Participants With Measurable Residual Disease (MRD) Conversion in Participants With MRD >= 10^-3 at Baseline (Part 2)
MRD conversion rate was defined as the percentage of participants who convert to MRD < 10^-3 after initiation of treatment. The population for MRD analysis included participants whose bone marrow was MRD positive (>=10^-3, as determined by central flow cytometry) at baseline prior to randomization.
Measured: Up to approximately 41 months
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
Time to deterioration was defined as number of days from randomization to either deterioration of >= 5 points based on the EORTC QLQ-C30 version 3 or death due to any cause. The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL.
Measured: Up to approximately 41 months
Change From Baseline in European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) Score
The EQ-5D-5L is a generic preference instrument that has been validated in numerous populations and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems) with higher scores representing higher symptom burden. A negative change from baseline indicates improvement in health status.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start26 Feb 2020
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161885
- Sponsor's protocol ID
- M19-063
- Other IDs
- 2023-507222-17-00, 2023
- Acronym
- VIALE-T
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.