NCT07537257

VEN+IDAC vs IDAC in AML

Venetoclax Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine for Consolidation Therapy of Acute Myeloid Leukemia (AML): a Multicenter, Prospective, Randomized Controlled, Phase 2 Study

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Guangdong Second Provincial General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.

Detailed description

Studies have shown that venetoclax can significantly enhance the efficacy of intensive chemotherapy (IC) in the induction and salvage treatment of AML. However, there is still a lack of direct comparison of the efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) with IDAC for consolidation in AML. In order to evaluate the benefit of venetoclax combined with IDAC, we plan to conduct a multicenter, prospective randomized controlled, phase 2 study to compare the efficacy and safety of venetoclax (d1-7, 400mg QD) combined with cytarabine (d1-3, 1.5g/㎡, q12h) versus cytarabine only for consolidation therapy in AML, aiming to fill the current evidence gap and provide scientific basis for improving deeper remission of AML and finally improve patients' long-term survival.

Conditions

• AML (Acute Myelogenous Leukemia)

Interventions

Type	Name	Description
DRUG	Ventoclax	Venetoclax 400mg per day from day 1 to day 7
DRUG	Cytarabine	Cytarabine 1.5g/m\^2 q12h from day 1 to day 3.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China