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NOT YET RECRUITING
NCT07335887
PHASE2

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

Official title: An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2026-01-01

Completion Date

2029-01-31

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

sonrotoclax

t(11;14) AL amyloidosis Newly diagnosed or previously untreated with anti-CD38 mAb therapy Induction therapy (C1-4) Sonrotoclax once daily ( dose depends on the 3+3 study design during safety run-in period in C1) Consolidation therapy (C5-12) Sonrotoclax once daily (same as the target dose in induction therapy) t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy Induction therapy (C1-4) Sonrotoclax once daily (dose depends on the 3+3 study design during safety run-in period in C1) Consolidation therapy (C5-12) Sonrotoclax once daily (same as the target dose in induction therapy)

DRUG

Daratumumab

t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy Daratumumab (16 mg/kg intravenously or 1800 mg subcutaneously, once weekly C1-2; every two weeks C3-6; every month C7-12)

DRUG

Dexamethasone

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.