A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival

Official Title

Randomized, Open-label, 2-Arm, Multicentre, 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)

Summary:

The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. 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. Part 3 will be the Dose Finding portion to determine levels of venetoclax in combination with Azacitidine (CC-486) to be explored. CC-486, and BSC may be administered for up to 24 cycles.

Trial Description

Primary Outcome:

• Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)
• Relapse-Free Survival (RFS) (Part 2)
• Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3)

• Overall Survival (OS)
• Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD)
• 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 2)
• 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 2)
• Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 2)
• Change From Baseline in Patient Reported Outcomes (PRO) in Items from European Quality-of-Life-5 Dimensional-5-Level (EQ5D5L) Between Arms A and B (Part 2)

View this trial on ClinicalTrials.gov