Condition: Systemic AL Amyloidosis · Sponsor: Peking University People's Hospital
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.
This description comes directly from the study's public registry record.
Yang Liu, M.D. · +86-13716926210 · pkuphliuyang@bjmu.edu.cn
Always discuss trial participation with your own doctor first.
| Peking University People's Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Fuxing Hospital affiliated to Capital Medical University | Beijing, Beijing Municipality, China | Recruiting |
| Beijing Anzhen Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Peking University First Hospital | Beijing, Beijing Municipality, China | Recruiting |
| First Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Recruiting |
| Chinese PLA Eastern Theater General Hospital | Nanjing, Jiangsu, China | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang, Liaoning, China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06627309