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History of Changes for Study: NCT04102020
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)
Latest version (submitted September 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 23, 2019 None (earliest Version on record)
2 November 12, 2019 Contacts/Locations, Study Status and Arms and Interventions
3 January 24, 2020 Contacts/Locations, Study Status, Arms and Interventions, Outcome Measures, Oversight, Eligibility and Study Description
4 February 27, 2020 Recruitment Status, Contacts/Locations and Study Status
5 March 24, 2020 Contacts/Locations and Study Status
6 May 6, 2020 Contacts/Locations and Study Status
7 May 29, 2020 Contacts/Locations, Study Status and Outcome Measures
8 June 11, 2020 Contacts/Locations, Study Status and Outcome Measures
9 July 9, 2020 Contacts/Locations, Study Status and IPDSharing
10 July 31, 2020 Contacts/Locations and Study Status
11 September 2, 2020 Contacts/Locations and Study Status
12 October 6, 2020 Contacts/Locations and Study Status
13 November 6, 2020 Contacts/Locations and Study Status
14 January 15, 2021 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Study Design, Eligibility and Study Description
15 February 11, 2021 Contacts/Locations, Study Status, Outcome Measures and Study Design
16 March 29, 2021 Contacts/Locations and Study Status
17 April 28, 2021 Study Status and Contacts/Locations
18 May 21, 2021 Contacts/Locations, Study Status and Outcome Measures
19 June 2, 2021 Contacts/Locations and Study Status
20 July 12, 2021 Contacts/Locations and Study Status
21 July 19, 2021 Contacts/Locations and Study Status
22 July 28, 2021 Contacts/Locations and Study Status
23 August 11, 2021 Contacts/Locations and Study Status
24 August 14, 2021 Contacts/Locations and Study Status
25 September 1, 2021 Contacts/Locations and Study Status
26 September 27, 2021 Contacts/Locations, Arms and Interventions, Study Design, Outcome Measures, Study Identification, Eligibility, Conditions, Study Description and Study Status
27 October 29, 2021 Contacts/Locations and Study Status
28 November 8, 2021 Contacts/Locations and Study Status
29 November 8, 2021 Contacts/Locations and Study Status
30 November 10, 2021 Contacts/Locations and Study Status
31 November 15, 2021 Contacts/Locations and Study Status
32 November 30, 2021 Contacts/Locations and Study Status
33 December 17, 2021 Contacts/Locations and Study Status
34 December 22, 2021 Contacts/Locations and Study Status
35 January 21, 2022 Contacts/Locations and Study Status
36 February 25, 2022 Contacts/Locations and Study Status
37 March 8, 2022 Study Status and Contacts/Locations
38 April 8, 2022 Study Status and Contacts/Locations
39 April 18, 2022 Contacts/Locations, IPDSharing and Study Status
40 April 19, 2022 Study Status
41 May 2, 2022 Contacts/Locations and Study Status
42 May 11, 2022 Contacts/Locations and Study Status
43 May 12, 2022 Contacts/Locations and Study Status
44 May 16, 2022 Contacts/Locations and Study Status
45 May 26, 2022 Contacts/Locations and Study Status
46 June 23, 2022 Contacts/Locations, IPDSharing and Study Status
47 July 19, 2022 Contacts/Locations and Study Status
48 July 26, 2022 Contacts/Locations and Study Status
49 July 27, 2022 Contacts/Locations and Study Status
50 August 11, 2022 Contacts/Locations and Study Status
51 September 1, 2022 Contacts/Locations and Study Status
52 September 19, 2022 Contacts/Locations and Study Status
53 September 21, 2022 Contacts/Locations and Study Status
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Study NCT04102020
Submitted Date:  September 23, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: M19-708
Brief Title: 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)
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)
Secondary IDs: 2019-002217-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2019
Overall Status: Not yet recruiting
Study Start: November 8, 2019
Primary Completion: September 10, 2024 [Anticipated]
Study Completion: May 17, 2025 [Anticipated]
First Submitted: September 23, 2019
First Submitted that
Met QC Criteria:
September 23, 2019
First Posted: September 25, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
September 23, 2019
Last Update Posted: September 25, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AbbVie
Responsible Party: Sponsor
Collaborators: Roche-Genentech
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study takes place in 2 parts evaluating improvement in relapse-free survival (RFS): Part 1 (Dose confirmation) and Part 2 (Randomization). Part 2 begins after safety is assessed in Part 1 for approximately 4 weeks. 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.
Detailed Description:
Open or close this module Conditions
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute myeloid leukemia (AML)
Venetoclax
Azacitidine
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 360 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1: Venetoclax + Azacitidine (AZA)
Participants will be administered with venetoclax 400 mg once daily (QD) (Days 1-28) up to 24 cycles and azacitidine (AZA) 50 mg/m^2 QD on Days 1-5 of each 28 day cycle up to 6 cycles.
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Experimental: Part 2: Arm A: Venetoclax + Azacitidine (AZA)
Participants will be administered with venetoclax 400 mg QD (Days 1-28) up to 24 cycles and azacitidine (AZA) 50 mg/m^2, on Days 1-5 of each 28-day cycle up to 6 cycles
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
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)
Drug: 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Relapse-Free Survival (RFS)
[ 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 relapse or 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".
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 (2017) 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).
Open or close this module Contacts/Locations
Central Contact Person: ABBVIE CALL CENTER
Telephone: 847.283.8955
Email: abbvieclinicaltrials@abbvie.com
Study Officials: AbbVie Inc.
Study Director
AbbVie
Locations: United States, Louisiana
Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic - Rochester /ID# 214686
Rochester, Minnesota, United States, 55905-0001
United States, Pennsylvania
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh, Pennsylvania, United States, 15232
Australia, New South Wales
St George Hospital /ID# 215416
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Gold Coast University Hospital /ID# 214650
Southport, Queensland, Australia, 4215
Germany
Uniklinikum Giessen-Marburg Gm /ID# 214734
Marburg, Germany, 35043
Germany, Sachsen
Universitaetsklinikum Leipzig /ID# 214440
Leipzig, Sachsen, Germany, 04103
Greece
Gen Univ Hosp Alexandroupolis /ID# 213870
Alexandroupolis, Greece, 68100
Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 213872
Athens, Greece, 115 21
University General Hospital of Heraklion "PA.G.N.I" /ID# 214075
Heraklion, Greece, 71110
Patras University General Hosp /ID# 213871
Rion, Patras, Achaia, Greece, 26504
Greece, Attiki
General Hospital of Athens Laiko /ID# 213869
Athens, Attiki, Greece, 115 27
University General Hospital Attikon /ID# 214298
Athens, Attiki, Greece, 12462
Korea, Republic of
Seoul National University Hospital /ID# 213943
Seoul, Korea, Republic of, 03080
Korea, Republic of, Busan Gwang Yeogsi
Pusan National University Hosp /ID# 213941
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Korea, Republic of, Gyeonggido
Seoul National Univ Bundang ho /ID# 215549
Seongnam, Gyeonggido, Korea, Republic of, 13620
Korea, Republic of, Seoul Teugbyeolsi
Samsung Medical Center /ID# 213940
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Taiwan
Kaohsiung Medical University /ID# 213953
Kaohsiung, Taiwan, 80708
Linkou Chang Gung Memorial Ho /ID# 213951
Taoyuan City, Taiwan, 33305
Taiwan, Taichung
China Medical University Hosp /ID# 213952
Taichung City, Taichung, Taiwan, 40447
Taiwan, Taipei
National Taiwan Univ Hosp /ID# 213939
Taipei City, Taipei, Taiwan, 10002
Turkey
Gulhane Askeri Tip Academy /ID# 214242
Ankara, Turkey, 06010
Ankara Univ Medical Faculty /ID# 214239
Ankara, Turkey, 6100
Turkey, Izmir
Medical Park İzmir Hastanesi /ID# 214238
Karşiyaka, Izmir, Turkey, 35575
Turkey, Kayseri
Erciyes University Medical Fac /ID# 214240
Melikgazi, Kayseri, Turkey, 38030
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
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
Open or close this module References
Links: Description: Related Info
Available IPD/Information:

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