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).
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 If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation.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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Chiglitazar Sodium in combination with Venetoclax and Azacitidine
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGComplete remission rate (CR)
The absolute neutrophil count is ≥1.0 × 10\^3/μL, the platelet count is ≥1.0 × 10\^5/μL, independent of red blood cell transfusions, and the percentage of bone marrow blasts is \<5%. There are no circulating bone marrow blasts and blasts with Auer rods in the peripheral blood; no extramedullary disease is present.
Time frame: Up to 36 months
Complete Remission with Incomplete Count Recovery (CRi)
Meeting all CR criteria except for residual neutropenia \<1.0 × 10\^3/μL (1000/μL) or thrombocytopenia \<1.0 × 10\^5/μL (100,000/μL). Dependence on red blood cell (RBC) transfusions is also defined as CRi.
Time frame: Up to 36 months
Partial remission rate (PR)
Meets all hematological criteria for CR, but the percentage of blasts in the bone marrow aspirate sample has decreased by at least 50%, reaching between 5% and 25%.
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.