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

a study on Acute Myeloid Leukemia Leukemia

Summary

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

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 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.

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)

Keywords

Acute Myeloid Leukemia (AML) Venetoclax Azacitidine CC-486 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 (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.

You CAN'T join if...

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

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04102020
Phase
Phase 3
Study Type
Interventional
Last Updated