drugset / Trial / NCT07514832

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

NCT07514832

Phase 2 Recruiting 48 enrolled Beijing 302 Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-15
Primary completion
2028-04-01
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Cytarabine Small molecule 100 mg/m2 Intravenous
Subject Idarubicin Small molecule 6 mg/m2 Intravenous
Subject Venetoclax Small molecule 400 mg Oral
Background G-CSF Unknown 200 ug/m2