NCT05918198

Clinical Study of Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

Clinical Study of BCL-2 Inhibitor Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.

Detailed description

The main questions it aims to answer are: * Safety of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients * Efficacy of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients Participants will receive therapy of venetoclax and CAG regimen (Ara-C, Acla and C C-GSF)

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ven+CAG	100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day. Ara-C 10mg/m2, ih, q12h × 14d； Acla 20mg/d × 4d； G-CSF 5ug/kg × 14d (WBC \> 30 × 10\^9/L pause)

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-06-26
• Last updated: 2023-11-21

Locations

1 site across 1 country: China