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Clinical Trial

Improving Care for Acute Myeloid Leukemia

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Venetoclax

Tablet: Oral

Drug - Azacitidine

Subcutaneous (SC) or intravenous (IV) injection

Best Supportive Care (BSC)

BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04102020

ParticipAid ID

aM8GAe