Clinical Research Directory
Browse clinical research sites, groups, and studies.
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Sponsor: Jin Lu, MD
Summary
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
Official title: Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2024-01-05
Completion Date
2027-03-31
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
Daratumumab
Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles. Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.
Bortezomib
All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
Dexamethasone
All patients received 20-40 mg oral or intravenous dexamethasone
Venetoclax
All patients received venetoclax 400mg daily.
Locations (6)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Capital Medical University Affiliated Fuxing Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China