Actively Recruiting
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Led by Jin Lu, MD · Updated on 2026-03-09
41
Participants Needed
6
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic AL amyloidosis
- Use of daratumumab, bortezomib, and dexamethasone in first-line treatment
- Life expectancy greater than 12 weeks
- Hemoglobin level of 70 g/L or higher
- Blood oxygen saturation greater than 90%
- Total bilirubin less than or equal to 3 times the upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal
- Informed consent explained, understood, and signed by the patient
You will not qualify if you...
- Diagnosis of active multiple myeloma or active lymphoplasmacytic lymphoma
- Presence of advanced malignant tumors with systemic metastasis
- Severe or persistent infection that cannot be controlled
- Severe autoimmune diseases or immunodeficiency
- Active hepatitis B or hepatitis C infection
- HIV infection or syphilis infection
- Any condition that increases risk or affects study results as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Capital Medical University Affiliated Fuxing Hospital
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
3
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 101118
Actively Recruiting
4
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
5
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266011
Actively Recruiting
6
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
Research Team
J
Jin Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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