NCT03844815

Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia

Phase 1 Study of Venetoclax in Combination With Decitabine 10-Day Regimen in Subjects With Acute Myeloid Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Decitabine	Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle) Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle). Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle
DRUG	Venetoclax	Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.

Timeline

• Start date: 2019-11-18
• Primary completion: 2027-12-10
• Completion: 2027-12-10
• First posted: 2019-02-18
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study