NCT06737523

Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).

Detailed description

1. Sogletanib 48mg per dose, once daily; Venetoclax 400mg per dose, once daily for 4 weeks; Azacitidine 100mg, once daily, days 1-7. 28 days/cycle, at least 2 cycles. 2. The drug concentration of Venetoclax will be tested one week after oral administration, and the dose will be adjusted according to the concentration. 3. After 2 treatment courses, patients with stable disease (SD) or progressive disease (PD) may receive up to 1-2 additional courses. If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation. Note: In special circumstances based on the patient's condition, laboratory test indicators, and adverse reactions, etc.; for Venetoclax dosage, if the white blood cell count is \>25×10\^9/L before administration, hydroxyurea may be given first to reduce the count to less than 25×10\^9/L before adding Venetoclax, and then the concentration of Venetoclax will be tested and the dose adjusted according to the concentration.

Conditions

• Acute Myeloid Leukemia
• Relapse
• Refractory AML

Interventions

Type	Name	Description
DRUG	CVA	Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-12-17
• Last updated: 2025-02-24

Locations

1 site across 1 country: China