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Trial record 1 of 1 for:    NCT04102020
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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 : November 16, 2021
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Venetoclax Drug: Azacitidine Drug: Placebo for Venetoclax Drug: CC-486 Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : November 12, 2026
Estimated Study Completion Date : October 21, 2027


Arm Intervention/treatment
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.
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta

Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection

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).
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta

Drug: CC-486
Tablet; Oral
Other Name: Azacitidine

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.
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta

Drug: CC-486
Tablet; Oral
Other Name: Azacitidine

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.
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta

Drug: CC-486
Tablet; Oral
Other Name: Azacitidine

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.
Drug: Placebo for Venetoclax
Tablet; Oral

Drug: CC-486
Tablet; Oral
Other Name: Azacitidine




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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 (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."

  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 (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".

  5. 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."

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102020


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Roche-Genentech
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04102020    
Other Study ID Numbers: M19-708
2019-002217-19 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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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
Keywords provided by AbbVie:
Acute myeloid leukemia (AML)
Venetoclax
Azacitidine
CC-486
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Venetoclax
Cc-486
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors