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

StatusRecruiting
PhasePhase 2
Started2026-02-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Peking University People's Hospital

Amendment history

2026-07-25
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Recruitment opened
Primary endpoint(s) modified1 entry, revised
WasBest hematological ≥VGPR rate within four cycles of therapy
Nowhematological ≥VGPR rate within four cycles of induction therapy
Trial sites expanded: 0 → 3 locations
Primary completion moved earlier: 2028-02-29 → 2027-12-31
Completion moved earlier: 2029-01-31 → 2028-08-31
Start dateestimated 2026-01-01→confirmed 2026-02-10
Secondary endpoints15 to 14 entries
Correlation analysis between different MRD satus groups and MOD-PFS, PFS and OS
2026-01-12
Original filing
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.
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