NCT05949762

Safety and Efficacy of Venetoclax in Combination With Azacitidine and HA Regimen in the Treatment of AML in the Elderly

The Second Affiliated Hospital of Kunming Medical University

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: ZePing Zhou · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This is a prospective phase II, single-arm clinical study that plans to enroll 45 patients aged 60 years or older with primary AML diagnosed after April 1, 2023.The purpose of this trial is to evaluate the efficacy of Venetoclax in combination with azacitidine and HA regimens in elderly patients aged \>60 years with primary acute myeloid leukemia and to provide evidence for optimal selection of clinical treatment regimens.

Detailed description

Patients diagnosed with primary AML according to morphology, immunophenotyping and medical history and meeting the exclusion criteria for enrollment: induction therapy with Venetoclax combined with azacitidine and HA regimen, after induction therapy up to CR, CRi, MLFS, according to ELN prognostic stratification and NCCN and Chinese guidelines for the treatment of adult AML (non-acute promyelocytic leukemia), according to patient risk stratification and treatment For patients with allogeneic hematopoietic stem cell transplantation due to various reasons (financial, physical, and other reasons), the patient will be recommended for transplantation. Patients who are not considered for allogeneic HSCT due to various reasons (financial, physical, donor constraints, etc.) will continue to receive two courses of intensive treatment with Venetoclax combined with a medium-dose Ara-c regimen and three courses of reduced-dose chemotherapy for consolidation. Patients completing intensive consolidation therapy enter maintenance treatment with Venetoclax in combination with azacitidine, danazol and thalidomide. Patients who do not achieve CR, CRi and MLFS with 1 course of induction therapy will be re-induced with the original regimen if they achieve PR. Patients who did not achieve PR on the first induction treatment and did not achieve CR, CRi, and MLFS after two induction treatments were dropped from the group and given salvage therapy. Patients with persistent positive MRD or recurrence during treatment were withdrawn from the group and given salvage therapy.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Venetoclax in Combination With Azacitidine and HA Regimen	Patients diagnosed with primary AML based on morphology, immunophenotyping, and history and meeting the inclusion exclusion criteria were induced with Venetoclax in combination with Azacitidine and HA regimen. Details for: Venetoclax 200mg d1-10 Azacitidine 100mg/d (or 50-75mg/m2/d), d2-7 Hautriacontin 2mg/m2/d, d3-7 Cytarabine 100mg/m2/d, d3-8 (infusion 24h)

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: China