Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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)

Keywords

Acute Myeloid Leukemia (AML) Venetoclax Azacitidine Maintenance Therapy Conventional Chemotherapy Best supportive care (BSC) Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • History of acute promyelocytic leukemia (APL).
  • History of active central nervous system involvement with acute myeloid leukemia (AML).

Locations

  • UCSD Moores Cancer Center - LaJolla /ID# 216065 not yet accepting patients
    La Jolla California 92093 United States
  • City of Hope /ID# 215672 not yet accepting patients
    Duarte California 91010 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT04102020
Phase
Phase 3
Study Type
Interventional
Last Updated