Project Title

M19-708 (VIALE-M)

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)

Project 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.

Blood Disorder

  • Acute Myeloid Leukaemia (AML)

Patient Recruitment Details

Patient recruitment status: Opening soon

Number of Patients (Globally)

Undetermined.