NCT05659992

Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

Detailed description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte	1. azacytidine (75 mg/m2/day, days 1 to 7). 2. cytarabine (75 mg/m2 bid, days 1 to 5). 3. aclamycin (10 mg/m2/day, day1,3,5). 4. Chidamide (30 mg/day , days 0,3). 5. venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ). 6. granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)

Timeline

• Start date: 2022-12-25
• Primary completion: 2023-08-14
• Completion: 2024-08-14
• First posted: 2022-12-21
• Last updated: 2024-11-08

Locations

1 site across 1 country: China