Clinical Trials Directory

Trials / Terminated

TerminatedNCT04161885

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
465 (actual)
Sponsor
AbbVie · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

Conditions

Interventions

TypeNameDescription
DRUGVenetoclaxTablet; Oral
DRUGAzacitidineSubcutaneous (SC) or intravenous (IV) injection
OTHERBest Supportive Care (BSC)BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Timeline

Start date
2020-02-26
Primary completion
2025-09-23
Completion
2025-09-23
First posted
2019-11-13
Last updated
2025-10-06

Locations

165 sites across 18 countries: United States, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04161885. Inclusion in this directory is not an endorsement.