NCT06192979

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Jin Lu, MD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Amyloidosis; Systemic
• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	Bortezomib	All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
DRUG	Dexamethasone	All patients received 20-40 mg oral or intravenous dexamethasone
DRUG	Venetoclax	All patients received venetoclax 400mg daily.

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-09-30
• Completion: 2027-03-31
• First posted: 2024-01-05
• Last updated: 2026-03-09

Locations

6 sites across 1 country: China