Status:
RECRUITING
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Lead Sponsor:
Jin Lu, MD
Conditions:
Amyloidosis; Systemic
AL Amyloidosis
Eligibility:
All Genders
Phase:
NA
Brief 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 B...
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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
- Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06192979
Start Date
January 5 2024
End Date
June 30 2026
Last Update
February 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044