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

AL Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192979
• Other study ID #: 2023PHB319-001
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Peking University People's Hospital
• Contact: Jin Lu
• Phone: +8613311491805
• Email: jin1lu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;

2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;

3. Life expectancy greater than 12 weeks;

4. HGB =70g/L;

5. Blood oxygen saturation >90%;

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

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

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

3. Severe or persistent infection that cannot be effectively controlled;

4. Presence of severe autoimmune diseases or immunodeficiency disease;

5. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);

6. Patients with HIV infection or syphilis infection;

7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• Amyloidosis; Systemic
• Immunoglobulin Light-chain Amyloidosis

Intervention

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.
• 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

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jin Lu, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall CHR rate at 6 months	Overall complete hematologic response rate at 6 months	Overall CHR rate at 6 months
Secondary	Cardiac response at 6 months	Cardiac response at 6 months	Cardiac response at 6 months
Secondary	Renal response at 6 months	Renal response at 6 months	Renal response at 6 months
Secondary	Hepatic response at 6 months	Hepatic response at 6 months	Hepatic response at 6 months
Secondary	Estimated 2-year PFS	Estimated 2-year progression free survival	Estimated 2-year PFS
Secondary	Estimated 2-year OS	Estimated 2-year overall survival	Estimated 2-year overall survival
Secondary	MRD status at 6 months	Minimal residual disease status at 6 months	MRD status at 6 months
Secondary	TRAEs	treatment-related adverse events up to 6 months	TRAEs