NCT07514832

VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial

A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \[G-CSF\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.

Conditions

• AML (Acute Myeloid Leukemia)

Interventions

Type	Name	Description
DRUG	Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF	* Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Day 3, and 400 mg on Days 4-14, orally, once daily; * Azacitidine: 75 mg/m²/d, subcutaneous injection, on Days 1-7; * Cytarabine: 100 mg/m²/d, intravenous infusion, on Days 1-5; * Idarubicin: 6 mg/m²/d, intravenous infusion, on Days 1-3; * Human granulocyte colony-stimulating factor (G-CSF): 200 μg/m²/d, subcutaneous injection, from Day 0 until the white blood cell count \> 10×10⁹/L. One cycle lasts for 28 days

Timeline

• Start date: 2026-04-15
• Primary completion: 2028-04-01
• Completion: 2028-12-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China