NCT04267081

Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening

Two-stage, Two-arm, Open-Label Phase II Study of Venetoclax in Combination With Azacytidine in Acute Myeloid Leukemia Patients Selected Using Ex Vivo Drug Sensitivity Screening

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a multi center two-stage, two-arm, open label phase II study of venetoclax in combination with azacytidine in acute myeloid leukemia patients selected for therapy with ex vivo venetoclax sensitivity screening. This study will characterize the usability of ex vivo drug sensitivity testing for patient selection for selecting the responsive patients for venetoclax therapy. The exploratory study will aim to find novel combinations for overcoming resistance as well as finding/validating biomarkers for both sensitivity and resistance.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Ex vivo venetoclax sensitivity testing is used for patient selection.

Timeline

• Start date: 2020-02-12
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2020-02-12
• Last updated: 2024-09-04

Locations

1 site across 1 country: Finland