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

Status: Recruiting
Location: See location...
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
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Jin Lu
jin1lu@sina.com
+8613311491805
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2026-06-30
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