NCT06192979Recruiting
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 12 Dec 2023
- Start date
- 5 Jan 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Jin Lu, MD
- Diseases
- Amyloidosis
- NCT number
- NCT06192979
What you commit to
- Study type: Interventional
- Planned participants: 41
- From 5 Jan 2024 to the primary completion date, 30 Sept 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Capital Medical University Affiliated Fuxing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chinese PLA Eastern Theater General Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Qilu Hospital of Shandong University (Qingdao) Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiao Tong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.