NCT05048615

Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Efficacy and Safety of Ambulatory Low-dose Venetoclax and Azacitidne as First Line Therapy in Newly Diagnosed AML: a Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.

Detailed description

Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy. This phase 2 clinical trial will explore the efficacy and safety of low-dose venetoclax (100mg /day/21 days) and a fixed dose of azacitidine (75mg/m2, maximun dose 100mg, SC for seven consecutive days) for a maximun of two cycles.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Venetoclax 100 MG	Patients will receive oral Venetoclax at a fixed dose of 100mg/day from day 1 to day 21 per cycle for a maximum of 2 cycles.
DRUG	Itraconazole capsule	Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.
DRUG	Azacitidine Injection	Patients will receive a maximum of two cycles of daily subcutaneous Azacitidine at a dose of 75 mg/m2 (maximum 100 mg) from day 1 to day 7.

Timeline

• Start date: 2021-07-26
• Primary completion: 2023-01-20
• Completion: 2023-01-20
• First posted: 2021-09-17
• Last updated: 2023-01-25

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study