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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital

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

Treatment groups

39 Participants
are divided into 1 treatment group

Locations

This trial has no locations