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A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

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ClinicalTrials.gov Identifier: NCT04102020
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : October 4, 2021
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 October 4, 2021
Actual Study Start Date  ICMJE March 26, 2020
Estimated Primary Completion Date November 12, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
    DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
  • Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion) [ Time Frame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months ]
    DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.
  • Relapse-Free Survival (RFS) (Part 3 Randomization Portion) [ 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
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Overall Survival (OS) (Part 3 Randomization Portion) [ Time Frame: Time from treatment to death from any cause, up to approximately 3 years ]
    OS is defined as the number of days from the date of randomization to the date of death.
  • Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) (Part 3 Randomization Portion) [ 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 (Part 3 Randomization Portion) [ 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 (Part 3 Randomization Portion) [ 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".
  • Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 3 Randomization Portion) [ 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) in Items from European Quality-of-Life-5 Dimesional-5-Level (EQ5D5L) Between Arms A and B (Part 3 Randomization Portion) [ Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized ]
    The EQ5D5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Original 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".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Official Title  ICMJE Randomized, Double-Blind, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Brief Summary This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be conducted in 2 phases - Dose Finding portion to determine RPTD of venetoclax in combination with CC-486 and Randomization portion to evaluate if venetoclax in combination with CC-486 as maintenance therapy improves relapse-free survival (RFS) compared to CC-486.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia (AML)
Intervention  ICMJE
  • Drug: Venetoclax
    Tablet: Oral
    Other Names:
    • ABT-199
    • GDC-0199
    • Venclexta
  • Drug: Azacitidine
    Subcutaneous (SC) or intravenous (IV) injection
  • Drug: Placebo for Venetoclax
    Tablet; Oral
  • Drug: CC-486
    Tablet; Oral
    Other Name: Azacitidine
Study Arms  ICMJE
  • Experimental: Part 1: Dose Confirmation
    Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
    Interventions:
    • Drug: Venetoclax
    • Drug: Azacitidine
  • Experimental: Part 3 (Dose Finding): Dose Escalation
    Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
    Interventions:
    • Drug: Venetoclax
    • Drug: CC-486
  • Experimental: Part 3 (Dose Finding): Safety Expansion
    Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
    Interventions:
    • Drug: Venetoclax
    • Drug: CC-486
  • Experimental: Part 3 (Randomization): Venetoclax + CC-486
    Participants will receive venetoclax QD, CC-486 QD on Days 1-14 of each 28-day cycle for 24 cycles.
    Interventions:
    • Drug: Venetoclax
    • Drug: CC-486
  • Experimental: Part 3 (Randomization): Placebo + CC-486
    Participants will receive Placebo for venetoclax QD, CC-486 QD on Days 1-14 of each 28-day cycle for 24 cycles.
    Interventions:
    • Drug: Placebo for Venetoclax
    • Drug: CC-486
Publications * Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637. Review.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2021)
482
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
360
Estimated Study Completion Date  ICMJE October 21, 2027
Estimated Primary Completion Date November 12, 2026   (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 (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
    • Achieved first CR + CRi within 120days of first dose of study drug or be no more than 75 days since last dose of intensive conventional chemotherapies.
    • AML has intermediate or poor 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 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   China,   Czechia,   France,   Germany,   Greece,   Hungary,   Israel,   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 Yes
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)
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 September 2021

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