Avapritinib Maintenance for AML With KIT Mutations

Korábbi kezelés

• concurrently receiving other targeted therapies for AML;
• Prior treatment with a TKI inhibitor that proved ineffective;
• with concurrent FLT3-ITD mutations at enrollment;
• Acute/chronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;

Más betegség

• Accompanied by other malignant tumors requiring treatment;
• Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure;
• Active, uncontrolled infection;
• HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy;
• The investigator believes that there are other conditions that make the patient unsuitable for participation in this study.

Egyéb

• Other interventional clinical studies have been enrolled;
• Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment;

• Age≥ 14 years old;
• First allo-HSCT for AML (including secondary AML) ;
• KIT mutation at diagnosis (no restriction on locus for kit mutation
• CR and negative MFC-MRD prior to initiation of maintenance therapy;
• Absolute neutrophil count ≥ 1.0 x 109 /L, platelets ≥ 75 x 109 /L, hemoglobin ≥ 80 g/L before maintenance;
• Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g/L (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\^9/L (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\^9/L (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;
• ECOG PS 0-2 points;
• Expected survival ≥ 3 months;
• Patient consent