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) (VIALE-M)

  • STATUS
    Recruiting
  • End date
    Oct 19, 2027
  • participants needed
    482
  • sponsor
    AbbVie
Updated on 20 October 2022
cancer
remission
azacitidine
consolidation chemotherapies
venetoclax

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.

Details
Condition Acute Myeloid Leukemia (AML)
Treatment Azacitidine, CC-486, venetoclax, best supportive care (BSC), Azacitidine (CC-486), Placebo for Venetoclax
Clinical Study IdentifierNCT04102020
SponsorAbbVie
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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