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Trial record 1 of 1 for:    NCT 04102020
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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102020
Recruitment Status : Active, not recruiting
First Posted : September 25, 2019
Last Update Posted : October 25, 2023
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Study Description
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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 the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 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
Actual Primary Completion Date : September 29, 2022
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Confirmation
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 48 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


Outcome Measures
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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 the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 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.


Eligibility Criteria
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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 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) 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).
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
AbbVie
Roche-Genentech
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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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: October 25, 2023
Last Verified: October 2023
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, 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
URL: https://vivli.org/ourmember/abbvie/

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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
Hematologic Diseases
Azacitidine
 Venetoclax
Cc-486
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors