Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Recruiting now · Not applicable
Conditions studied: Amyloidosis; Systemic, AL Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT06192979
- Run by
- Jin Lu, MD
- People needed
- 41
- Starts
- 2024-01-05
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-07-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- Capital Medical University Affiliated Fuxing Hospital — Beijing, Beijing Municipality, China (enrolling)
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (enrolling)
- Chinese PLA Eastern Theater General Hospital — Nanjing, Jiangsu, China (enrolling)
- Qilu Hospital of Shandong University (QingDao) — Qingdao, Shandong, China (enrolling)
- Qingdao Municipal Hospital — Qingdao, Shandong, China (enrolling)
- The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an, Shanxi, China (enrolling)
Full record on ClinicalTrials.gov
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