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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) (VIALE-T)

Primary Purpose

Acute Myeloid Leukemia (AML), Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Azacitidine
Best Supportive Care (BSC)
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia (AML), Venetoclax, Azacitidine, Stem Cell Transplantation (SCT), Best Support Care (BSC), Cancer

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711Recruiting
  • University of Arizona Cancer Center - Tucson /ID# 242507Recruiting
  • University of Arkansas for Medical Sciences /ID# 239804Recruiting
  • City of Hope /ID# 213681Recruiting
  • UCHSC Anschultz Cancer Pavilion /ID# 215618Recruiting
  • Colorado Blood Cancer Institute /ID# 215980Recruiting
  • Mayo Clinic /ID# 239710Recruiting
  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985Recruiting
  • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840Recruiting
  • The University of Chicago Medical Center /ID# 215616Recruiting
  • Loyola University Medical Ctr /ID# 215617Recruiting
  • Indiana Blood & Marrow Transpl /ID# 215842Recruiting
  • Ochsner Clinic Foundation-New Orleans /ID# 213834Recruiting
  • University of Maryland Med Ctr /ID# 213855Recruiting
  • Massachusetts General Hospital /ID# 215765Recruiting
  • Karmanos Cancer Institute - Dresner Clinic /ID# 214581Recruiting
  • Masonic Cancer Center /ID# 239492Recruiting
  • Mayo Clinic - Rochester /ID# 214685Recruiting
  • University of Mississippi Medical Center /ID# 239343Recruiting
  • The John Theurer Cancer /ID# 215251Recruiting
  • Montefiore Medical Center - Moses Campus /ID# 241669Recruiting
  • Roswell Park Comprehensive Cancer Center /ID# 217857Recruiting
  • Columbia University Medical Center /ID# 240875Recruiting
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680Recruiting
  • Weill Cornell Medical College /ID# 214887
  • University of North Carolina /ID# 215814Recruiting
  • Wake Forest Univ HS /ID# 239210Recruiting
  • UC Health - Cincinnati /ID# 239263Recruiting
  • University Hospitals - Seidman Cancer Center /ID# 239260Recruiting
  • University of Oklahoma, Stephenson Cancer Center /ID# 215611Recruiting
  • Oregon Health & Science University /ID# 215874Recruiting
  • Penn State Hershey Medical Ctr /ID# 217120Recruiting
  • Children's Hospital of Philadelphia - Main /ID# 215410Recruiting
  • Perelman Center for Advanced Medicine - /ID# 214518Recruiting
  • Allegheny General Hospital /ID# 216756Recruiting
  • UPMC Hillman Cancer Ctr /ID# 213715Recruiting
  • TriStar Centennial Medical Center /ID# 218750Recruiting
  • Texas Oncology - Medical City Dallas /ID# 216720Recruiting
  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735Recruiting
  • Texas Transplant Institute /ID# 214691
  • Virginia Commonwealth University Medical Center Main Hospital /ID# 239203Recruiting
  • Fred Hutchinson Cancer Research Center /ID# 214436Recruiting
  • Univ of Wisconsin Hosp/Clinics /ID# 216096Recruiting
  • The Kinghorn Cancer Centre /ID# 214660Recruiting
  • Royal Adelaide Hospital /ID# 215678Recruiting
  • Peter MacCallum Cancer Ctr /ID# 214653Recruiting
  • Alfred Health /ID# 240931Recruiting
  • Hospital de Clinicas de Porto Alegre /ID# 215042Recruiting
  • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145Recruiting
  • Hospital Nove de Julho /ID# 242359Recruiting
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516Recruiting
  • Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363Recruiting
  • Princess Margaret Cancer Centre /ID# 215344Recruiting
  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591Recruiting
  • Royal Victoria Hospital / McGill University Health Centre /ID# 215253Recruiting
  • Saskatoon Cancer Centre /ID# 238821Recruiting
  • Peking University People's Hospital /ID# 215551Recruiting
  • Chinese PLA General Hospital /ID# 216287Recruiting
  • Aerospace Center Hospital /ID# 217018Recruiting
  • Fujian Medical University Union Hospital /ID# 215555Recruiting
  • Guangdong Provincial People's Hospital /ID# 218666Recruiting
  • Zhujiang Hospital of Southern Medical University /ID# 216333Recruiting
  • Nanfang Hospital of Southern Medical University /ID# 215553Recruiting
  • Shenzhen Second People's Hospital /ID# 239401Recruiting
  • Henan Cancer Hospital /ID# 215554Recruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552Recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373Recruiting
  • Xiangya Hospital Central South University /ID# 219025Recruiting
  • Zhongda Hospital Southeast University /ID# 218926Recruiting
  • The First Affiliated Hospital of Soochow University /ID# 216605Recruiting
  • The Affiliated Hospital of Xuzhou Medical University /ID# 239098Recruiting
  • The First Affiliated Hospital of Nanchang University /ID# 239168Recruiting
  • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282Recruiting
  • Shanghai Changhai Hospital /ID# 216334Recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550Recruiting
  • Fakultni Nemocnice Brno /ID# 214811Recruiting
  • Fakultni nemocnice Hradec Kralove /ID# 214814Recruiting
  • Fakultni nemocnice Ostrava /ID# 239922Recruiting
  • Ustav hematologie a krevni transfuze /ID# 215133Recruiting
  • CHU de Nice - Hôpital Archet 1 /ID# 214056Recruiting
  • CHU de Besancon - Jean Minjoz /ID# 241171Recruiting
  • CHU Bordeaux - Hopital Haut Leveque /ID# 214055Recruiting
  • CHRU Lille - Hopital Claude Huriez /ID# 217916Recruiting
  • CHU de Nantes, Hotel Dieu -HME /ID# 214060Recruiting
  • AP-HP - Hopital Saint-Louis /ID# 214054Recruiting
  • AP-HP - Hopital Saint-Antoine /ID# 216957Recruiting
  • Hopital Pitie Salpetriere /ID# 241072Recruiting
  • Universitaetsklinik Heidelberg /ID# 216623Recruiting
  • Universitaetsklinikum Muenster /ID# 215213Recruiting
  • Universitaetsklinikum Leipzig /ID# 245892Recruiting
  • Klinikum Augsburg /ID# 239583Recruiting
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244Recruiting
  • Universitaetsklinikum Halle (Saale) /ID# 239585Recruiting
  • Medizinische Hochschule Hannover /ID# 214243Recruiting
  • Universitaetsklinikum Wuerzburg /ID# 215212
  • General Hospital of Athens Evangelismos /ID# 238810Recruiting
  • University General Hospital Attikon /ID# 238812Recruiting
  • University General Hospital of Patras /ID# 238811Recruiting
  • Debreceni Egyetem Klinikai Kozpont /ID# 241123Recruiting
  • The Chaim Sheba Medical Center /ID# 214305Recruiting
  • Tel Aviv Sourasky Medical Center /ID# 214508Recruiting
  • Hadassah Medical Center-Hebrew University /ID# 218697Recruiting
  • Rambam Health Care Campus /ID# 214507Recruiting
  • Schneider Children's Medical Center /ID# 224326Recruiting
  • Rabin Medical Center /ID# 214509Recruiting
  • Sheba Medical Center /ID# 239571Recruiting
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910Recruiting
  • Ospedale San Raffaele IRCCS /ID# 214311Recruiting
  • IEO -Istituto Europeo di Oncologia /ID# 242579Recruiting
  • ASST Spedali civili di Brescia /ID# 215997Recruiting
  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148Recruiting
  • Anjou Kousei Hospital /ID# 215857Recruiting
  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679Recruiting
  • University of Fukui Hospital /ID# 253383Recruiting
  • Kyushu University Hospital /ID# 215285Recruiting
  • Fukushima Medical University Hospital /ID# 252293Recruiting
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522Recruiting
  • Hokkaido University Hospital /ID# 215937Recruiting
  • Kobe City Medical Center General Hospital /ID# 215388Recruiting
  • Hyogo Medical University Hospital /ID# 215389Recruiting
  • Kanazawa University Hospital /ID# 242955Recruiting
  • Imamura General Hospital /ID# 215688Recruiting
  • Tokai University Hospital /ID# 250086Recruiting
  • Kanagawa Cancer Center /ID# 215029Recruiting
  • Kyoto University Hospital /ID# 243209Recruiting
  • Tohoku University Hospital /ID# 214670Recruiting
  • Okayama University Hospital /ID# 214842Recruiting
  • Osaka Metropolitan University Hospital /ID# 215227Recruiting
  • Kindai University Hospital /ID# 214917Recruiting
  • Jichi Medical University Saitama Medical Center /ID# 216092Recruiting
  • Jichi Medical University Hospital /ID# 216091Recruiting
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
  • National Cancer Center Hospital /ID# 242639Recruiting
  • Toranomon Hospital /ID# 215311Recruiting
  • National Center for Child Health and Development /ID# 242479Recruiting
  • Keio University Hospital /ID# 243549Recruiting
  • Yamagata University Hospital /ID# 253304Recruiting
  • Seoul National University Hospital /ID# 214891Recruiting
  • Asan Medical Center /ID# 214893Recruiting
  • Samsung Medical Center /ID# 239087Recruiting
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892Recruiting
  • Hospital Clinic de Barcelona /ID# 215108Recruiting
  • Hospital Santa Creu i Sant Pau /ID# 240397Recruiting
  • Hospital General Universitario Gregorio Maranon /ID# 215107Recruiting
  • Hospital Universitario Ramon y Cajal /ID# 218102Recruiting
  • Hospital Universitario La Paz /ID# 218103Recruiting
  • Hospital Universitario Virgen del Rocio /ID# 215463Recruiting
  • Hospital Clinico Universitario de Valencia /ID# 215106Recruiting
  • Universitätsspital Basel /ID# 215892Recruiting
  • Universitatsspital Zurich /ID# 215891Recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197Recruiting
  • China Medical University Hospital /ID# 215198Recruiting
  • Taichung Veterans General Hospital /ID# 239288Recruiting
  • National Taiwan University Hospital /ID# 215245Recruiting
  • Taipei Veterans General Hosp /ID# 239289Recruiting
  • Linkou Chang Gung Memorial Hospital /ID# 215319Recruiting
  • NHS Greater Glasgow and Clyde /ID# 215663Recruiting
  • University Hospitals Birmingham NHS Foundation Trust /ID# 215120Recruiting
  • University College London Hospitals NHS Foundation Trust /ID# 215662Recruiting
  • King's College Hospital NHS Foundation Trust /ID# 215338Recruiting
  • The Royal Marsden NHS Foundation Trust /ID# 215124Recruiting
  • Imperial College Healthcare NHS Trust /ID# 215665Recruiting
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

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

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

Arm Description

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)

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).

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Morphologic Relapse-Free Survival (RFS) (Part 2)
Morphologic relapse from AML 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 Independent Review Committee (IRC).
Composite Relapse-Free Survival (RFS) (Part 2)
Morphologic relapse from AML, non-morphologic relapse from AML, which is 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 comes first as determined by IRC.
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)
GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR incidence of GvHD OR death from any cause.
Graft-versus-Host Disease (GvHD) Rate (Part 2)
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.
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)
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).
Change From Randomization in Fatigue in Adult Participants (Part 2)
Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.
Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)
MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
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.
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)
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.

Full Information

First Posted
November 11, 2019
Last Updated
September 6, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04161885
Brief Title
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)
Acronym
VIALE-T
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML), Cancer
Keywords
Acute Myeloid Leukemia (AML), Venetoclax, Azacitidine, Stem Cell Transplantation (SCT), Best Support Care (BSC), Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care
Arm Type
Experimental
Arm Description
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)
Arm Title
Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC
Arm Type
Experimental
Arm Description
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).
Arm Title
Part 2: Arm B - Best Supportive Care (BSC)
Arm Type
Experimental
Arm Description
Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, VENCLEXTA
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Subcutaneous (SC) or intravenous (IV) injection
Intervention Type
Other
Intervention Name(s)
Best Supportive Care (BSC)
Intervention Description
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Primary Outcome Measure Information:
Title
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
Description
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.
Time Frame
Up to the first treatment cycle (28 days)
Title
Overall Survival (OS) (Part 2)
Description
OS is defined as the number of days from the date of randomization to the date of death from any cause.
Time Frame
Up to 45 months after the first participant is randomized
Secondary Outcome Measure Information:
Title
Morphologic Relapse-Free Survival (RFS) (Part 2)
Description
Morphologic relapse from AML 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 Independent Review Committee (IRC).
Time Frame
Up to 39 months after the first participant is randomized
Title
Composite Relapse-Free Survival (RFS) (Part 2)
Description
Morphologic relapse from AML, non-morphologic relapse from AML, which is 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 comes first as determined by IRC.
Time Frame
Up to 39 months after the first participant is randomized
Title
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)
Description
GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR incidence of GvHD OR death from any cause.
Time Frame
Up to 39 months after the first participant is randomized
Title
Graft-versus-Host Disease (GvHD) Rate (Part 2)
Description
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.
Time Frame
Up to 39 months after the first participant is randomized
Title
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)
Description
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).
Time Frame
Up to 39 months after the first participant is randomized
Title
Change From Randomization in Fatigue in Adult Participants (Part 2)
Description
Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.
Time Frame
Up to 39 months after the first participant is randomized
Title
Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)
Description
MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.
Time Frame
Up to 39 months after the first participant is randomized
Title
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
Description
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.
Time Frame
Up to 39 months after the first participant is randomized
Title
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)
Description
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.
Time Frame
Up to 39 months after the first participant is randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2. Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4547
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arizona Cancer Center - Tucson /ID# 242507
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arkansas for Medical Sciences /ID# 239804
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope /ID# 213681
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
UCHSC Anschultz Cancer Pavilion /ID# 215618
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Colorado Blood Cancer Institute /ID# 215980
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Mayo Clinic /ID# 239710
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804-5505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
The University of Chicago Medical Center /ID# 215616
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Individual Site Status
Recruiting
Facility Name
Loyola University Medical Ctr /ID# 215617
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Indiana Blood & Marrow Transpl /ID# 215842
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Clinic Foundation-New Orleans /ID# 213834
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Maryland Med Ctr /ID# 213855
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Massachusetts General Hospital /ID# 215765
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Karmanos Cancer Institute - Dresner Clinic /ID# 214581
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Masonic Cancer Center /ID# 239492
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Rochester /ID# 214685
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Mississippi Medical Center /ID# 239343
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4500
Country
United States
Individual Site Status
Recruiting
Facility Name
The John Theurer Cancer /ID# 215251
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Montefiore Medical Center - Moses Campus /ID# 241669
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Comprehensive Cancer Center /ID# 217857
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Columbia University Medical Center /ID# 240875
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College /ID# 214887
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Completed
Facility Name
University of North Carolina /ID# 215814
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Univ HS /ID# 239210
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Health - Cincinnati /ID# 239263
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-2800
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals - Seidman Cancer Center /ID# 239260
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma, Stephenson Cancer Center /ID# 215611
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5418
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University /ID# 215874
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Penn State Hershey Medical Ctr /ID# 217120
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Children's Hospital of Philadelphia - Main /ID# 215410
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Individual Site Status
Recruiting
Facility Name
Perelman Center for Advanced Medicine - /ID# 214518
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Allegheny General Hospital /ID# 216756
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
UPMC Hillman Cancer Ctr /ID# 213715
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
TriStar Centennial Medical Center /ID# 218750
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1551
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Texas Oncology - Medical City Dallas /ID# 216720
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Texas Transplant Institute /ID# 214691
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
Virginia Commonwealth University Medical Center Main Hospital /ID# 239203
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center /ID# 214436
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Univ of Wisconsin Hosp/Clinics /ID# 216096
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
608-265-4729
Facility Name
The Kinghorn Cancer Centre /ID# 214660
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital /ID# 215678
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Ctr /ID# 214653
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health /ID# 240931
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 215042
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
City
Jaú
State/Province
Sao Paulo
ZIP/Postal Code
17210-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Nove de Julho /ID# 242359
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01409-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre /ID# 215344
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 215253
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Saskatoon Cancer Centre /ID# 238821
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital /ID# 215551
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese PLA General Hospital /ID# 216287
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Name
Aerospace Center Hospital /ID# 217018
City
Beijing
State/Province
Beijing
ZIP/Postal Code
861059
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital /ID# 215555
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital /ID# 218666
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University /ID# 216333
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital of Southern Medical University /ID# 215553
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen Second People's Hospital /ID# 239401
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518025
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital /ID# 215554
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital Central South University /ID# 219025
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital Southeast University /ID# 218926
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University /ID# 216605
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Xuzhou Medical University /ID# 239098
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 239168
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Changhai Hospital /ID# 216334
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 214811
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 214814
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava /ID# 239922
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ustav hematologie a krevni transfuze /ID# 215133
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU de Nice - Hôpital Archet 1 /ID# 214056
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Besancon - Jean Minjoz /ID# 241171
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 214055
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 217916
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 214060
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Louis /ID# 214054
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Antoine /ID# 216957
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie Salpetriere /ID# 241072
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinik Heidelberg /ID# 216623
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster /ID# 215213
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig /ID# 245892
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Augsburg /ID# 239583
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 239585
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover /ID# 214243
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Wuerzburg /ID# 215212
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Completed
Facility Name
General Hospital of Athens Evangelismos /ID# 238810
City
Athens
State/Province
Attiki
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital Attikon /ID# 238812
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Patras /ID# 238811
City
RION Patras Achaia
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 241123
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 214305
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 214508
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center-Hebrew University /ID# 218697
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus /ID# 214507
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Schneider Children's Medical Center /ID# 224326
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 214509
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center /ID# 239571
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele IRCCS /ID# 214311
City
Milan
State/Province
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IEO -Istituto Europeo di Oncologia /ID# 242579
City
Milan
State/Province
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali civili di Brescia /ID# 215997
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Anjou Kousei Hospital /ID# 215857
City
Anjo-shi
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Fukui Hospital /ID# 253383
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital /ID# 215285
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital /ID# 252293
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 215937
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital /ID# 215388
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Medical University Hospital /ID# 215389
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital /ID# 242955
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Imamura General Hospital /ID# 215688
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital /ID# 250086
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center /ID# 215029
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital /ID# 243209
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital /ID# 214670
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital /ID# 214842
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital /ID# 215227
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital /ID# 214917
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi Medical University Saitama Medical Center /ID# 216092
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi Medical University Hospital /ID# 216091
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Completed
Facility Name
National Cancer Center Hospital /ID# 242639
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toranomon Hospital /ID# 215311
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Child Health and Development /ID# 242479
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital /ID# 243549
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital /ID# 253304
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 214891
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center /ID# 214893
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center /ID# 239087
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona /ID# 215108
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Santa Creu i Sant Pau /ID# 240397
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 215107
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal /ID# 218102
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz /ID# 218103
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 215463
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia /ID# 215106
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitätsspital Basel /ID# 215892
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitatsspital Zurich /ID# 215891
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital /ID# 215198
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital /ID# 239288
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital /ID# 215245
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hosp /ID# 239289
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 215319
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
NHS Greater Glasgow and Clyde /ID# 215663
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 215120
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 215662
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
King's College Hospital NHS Foundation Trust /ID# 215338
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Foundation Trust /ID# 215124
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare NHS Trust /ID# 215665
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-063
Description
Related Info

Learn more about this trial

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

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