Clinical Trial

Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis

Recruiting Phase 2
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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.
Protocol Amendment History 5 changes
critical Recruitment opened 2026-07-29
critical Primary endpoint(s) modified 2026-07-29
notable Trial sites expanded: 0 -> 3 locations 2026-07-29
notable Primary completion moved earlier: 2028-02-29 -> 2027-12-31 2026-07-29
minor Completion moved earlier: 2029-01-31 -> 2028-08-31 2026-07-29
Trial Details
NCT Number NCT07335887
Lead Sponsor Peking University People's Hospital
Conditions AL Amyloidosis (AL), t(11;14) Positive
Enrollment 39 participants
Start Date 2026-02-10
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28