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A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Oct 2025 to Dec 15, 2025
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 treatment paradigm for AL amyloidosis has undergone significant changes, and the prognosis has improved dramatically. Achieving very good partial response (VGPR) or even complete response (CR) can lead to higher organ response and longer survival. However, not all patients who achieve ≥VGPR reach organ response, which may be related to the presence of small residual plasma cell clones in these patients. The ongoing production of monoclonal light chains deposits into tissues and organs, causing continuous damage, making organ response difficult. With the development of new drugs, the rate of hematologic CR has continuously increased, and the advancement of minimal residual disease (MRD) detection technologies in recent years has led to increasing attention to MRD in AL amyloidosis research. Therefore, in this era of advancing new drugs, MRD negativity may become a higher clinical treatment goal for AL amyloidosis, further improving long-term prognosis for patients. Our department plans to conduct a single-center, prospective clinical study aimed at exploring the MRD status in patients who achieve hematologic CR after first-line induction chemotherapy (Dara-CyBorD), and further investigating whether autologous stem cell transplantation in MRD-positive CR patients who meet transplant criteria can further improve organ response, progression-free survival, and overall survival.
Trial Details
NCT Number NCT07215494
Lead Sponsor Peking University First Hospital
Collaborators: Beijing Chao Yang Hospital, Beijing Anzhen Hospital
Conditions
(from sponsor)
Light Chain (AL) Amyloidosis, MRD
Related terms Amyloidosis, Immunoglobulin Light-chain Amyloidosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov