Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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 azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Official Title

A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

Keywords

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

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 (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.

You CAN'T join if...

Locations

  • University of California, Los Angeles /ID# 219149
    Los Angeles California 90095 United States
  • Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
    Fountain Valley California 92708-7501 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT04102020
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 112 people participating
Last Updated