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About
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).
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Interventional model
Masking
465 participants in 3 patient groups
There are currently no registered sites for this trial.
Central trial contact
ABBVIE CALL CENTER
Start date
Feb 26, 2020 • 5 years ago
Today
Mar 30, 2025
End date
Apr 01, 2025 • in 1 day
Lead Sponsor
Data sourced from clinicaltrials.gov
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