NCT05404906

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

Conditions

• Acute Myeloid Leukemia (AML) in Remission

Interventions

Type	Name	Description
DRUG	Azacitidine	Given SC
DRUG	Venetoclax	Given PO
OTHER	Supportive care	Patients will receive disease monitoring and supportive care for any complication.

Timeline

• Start date: 2022-06-25
• Primary completion: 2028-06-01
• Completion: 2030-06-01
• First posted: 2022-06-03
• Last updated: 2022-08-19

Locations

2 sites across 1 country: China