Primary Amyloidosis Clinical Trials

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Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of systemic AL amyloidosis;

• Daratumumab, bortezomib, dexamethasone used in 1st line treatment;

• Life expectancy greater than 12 weeks;

• HGB ≥70g/L;

• Blood oxygen saturation \>90%;

• Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;

• Informed consent explained to, understood by and signed by the patient.

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Capital Medical University Affiliated Fuxing Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Chinese PLA Eastern Theater General Hospital
RECRUITING
Nanjing
Qingdao Municipal Hospital
RECRUITING
Qingdao
The First Affiliated Hospital of Xi'an Jiao Tong University
RECRUITING
Xi’an
Contact Information
Primary
Jin Lu
jin1lu@sina.com
+8613311491805
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 41
Treatments
Other: Rapid Response Group
Daratumumab, bortezomib, dexamethasone
Other: Non-Rapid Response Group
Daratumumab, venetoclax, dexamethasone
Related Therapeutic Areas
Sponsors
Leads: Jin Lu, MD

This content was sourced from clinicaltrials.gov