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

Official Title

Randomized, Double-Blind, 2-Arm, Multicentre, 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)

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.

Trial Description

Primary Outcome:

• Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)
• Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)
• Relapse-Free Survival (RFS) (Part 3 Randomization Portion)

• Overall Survival (OS) (Part 3 Randomization Portion)
• Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) (Part 3 Randomization Portion)
• Time to Deterioration in Global Health Status (GHS)/Quality-of Life (QoL) Score Based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30-Item (EORTC QLQ-C30) Scoring Manual (Part 3 Randomization Portion)
• Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a (Part 3 Randomization Portion)
• Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 3 Randomization Portion)
• Change From Baseline in Patient Reported Outcomes (PRO) in Items from European Quality-of-Life-5 Dimesional-5-Level (EQ5D5L) Between Arms A and B (Part 3 Randomization Portion)

View this trial on ClinicalTrials.gov