Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102020
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date November 14, 2019
Estimated Study Start Date  ICMJE January 18, 2020
Estimated Primary Completion Date September 10, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04102020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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.
  • 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.
  • 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."
  • 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".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia (AML)
Intervention  ICMJE
  • Drug: Venetoclax
    Tablet: Oral
    Other Names:
    • ABT-199
    • GDC-0199
  • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection
  • Other: Best Supportive Care (BSC)
    BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Venetoclax
    • Drug: Azacitidine
  • 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
    Interventions:
    • Drug: Venetoclax
    • Drug: Azacitidine
  • 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)
    Intervention: Other: Best Supportive Care (BSC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2025
Estimated Primary Completion Date September 10, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Puerto Rico,   Russian Federation,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102020
Other Study ID Numbers  ICMJE M19-708
2019-002217-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Roche-Genentech
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP