An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis
The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.
• Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).
• Age ≥ 18 years.
• Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity
• ECOG Performance Status score of 0-2.
• Presence of measurable disease, defined by at least one of the following criteria:
∙ Serum M-protein ≥ 0.5 g/dL
‣ Serum free light chain (FLC) level ≥ 40 mg/L with an abnormal kappa/lambda ratio.
• Adequate organ function, defined as:
∙ Hemoglobin (HGB) \> 80 g/L
‣ Platelet count \> 50 × 10⁹/L
‣ Absolute neutrophil count (ANC) \> 1.0 × 10⁹/L
‣ Total bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3.0 × ULN
‣ Creatinine clearance (CrCl) ≥ 30 mL/min
‣ Oxygen saturation ≥ 90%
• Life expectancy greater than 6 months.
• Patient understands and voluntarily signs an informed consent form (ICF).
• Cohort Assignment:
‣ Cohort A: Includes patients who are newly diagnosed or have not been previously exposed to anti-CD38 monoclonal antibody therapy.
⁃ Cohort B: Includes patients who are insensitive to or have relapsed after anti-CD38 monoclonal antibody therapy.Insensitivity to anti-CD38 monoclonal antibody therapy is defined as failure to achieve at least a Partial Response (PR) after 1 cycle, or failure to achieve at least a Very Good Partial Response (VGPR) after 3 cycles of an anti-CD38-containing regimen.