Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis
An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis
Peking University People's Hospital
39 participants
Feb 10, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
cohor A \& Cohort B: Induction therapy (C1-4) : Sonrotoclax once daily A conventional 3+3 design will determine the target sonrotoclax dose during the C1 safety run-in phase. And dose-limiting toxicity (DLT) assessed during a 28-day evaluation window. Patients who are enrolled after the safety run-in phase will receive sonrotoclax at the dose determined in safety run-in phase. A 3-day ramp-up is used (320 mg: 80→160→320 mg on D1-D3; 640 mg: 160→320→640 mg on D1-D3) in C1, with the Day 3 dose maintained from Day 4 onward for all patients. Subsequent therapy (C5-12) Sonrotoclax once daily (same dose as in the induction phase)
Cohor A Only Daratumumab (16 mg/kg intravenously) or daratumumab and hyaluronidase-fihj (1800 mg subcutaneously)once weekly C1-2; every two weeks C3-6; every month C7-12
cohor A \& Cohort B: Dexamethasone (40 mg, once weekly) for 12 cycles. The dose was halved for patients 75 years of age or older, and in patients who were intolerant of dexamethasone, as judged by the investigators.
Locations(3)
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NCT07335887