NCT05805098

Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Detailed description

This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before. In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML. This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.
DRUG	Homoharringtonine	On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
DRUG	Cytarabine	On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-03-01
• Completion: 2028-03-01
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: China