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Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
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.
The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 5, 2024
Primary Completion Date
September 30, 2026
Completion Date
March 31, 2027
Last Updated
March 9, 2026
41
ESTIMATED participants
Daratumumab
DRUG
Bortezomib
DRUG
Dexamethasone
DRUG
Venetoclax
DRUG
Lead Sponsor
Jin Lu, MD
NCT07250269
NCT04839003
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05066607