Status:
NOT_YET_RECRUITING
A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Beijing Chao Yang Hospital
Beijing Anzhen Hospital
Conditions:
Light Chain (AL) Amyloidosis
MRD
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Before effective treatment, the prognosis of patients with AL amyloidosis is very poor, with a median survival of approximately 12 months. In recent decades, with the development of new drugs, the tre...
Detailed Description
Light chain amyloidosis (AL amyloidosis), as a plasma cell disorder, is caused by a typically small and slowly proliferating clone of plasma cells in the bone marrow. The light chains produced by this...
Eligibility Criteria
Inclusion
- Age range: 18-70 years (inclusive), no gender restriction;
- Newly diagnosed AL amyloidosis patients;
- Meet ASCT eligibility criteria and have a willingness to undergo ASCT;
- Achieved hematological complete response (CR) after 2-4 cycles of Dara-CyBorD induction chemotherapy.
Exclusion
- Secondary to multiple myeloma or lymphoplasmacytic lymphoma, such as Waldenström's macroglobulinemia;
- Co-existing other active malignant tumors;
- Co-existing other systemic diseases deemed unsuitable for inclusion by the investigator, such as newly developed severe cardiovascular and cerebrovascular diseases, or severe infections.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07215494
Start Date
October 1 2025
End Date
September 1 2029
Last Update
October 10 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034