About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma
Presence of other malignancies at an advanced stage with systemic metastases.
IgM-type AL amyloidosis.
Prior treatment with a BCL-2 inhibitor (BCL-2i).
Trial design
Treatments tested in this trial
- sonrotoclax
- Daratumumab
- Dexamethasone