NCT06192979 Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
| NCT ID | NCT06192979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jin Lu, MD |
| Condition | Amyloidosis; Systemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 41 participants in total. It began in 2024-01-05 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Jin Lu
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06192979 clinical trial?
This trial is open to participants of all sexes, studying Amyloidosis; Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06192979 currently recruiting?
Yes, NCT06192979 is actively recruiting participants. Contact the research team at jin1lu@sina.com for enrollment information.
Where is the NCT06192979 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Nanjing, China and 2 additional locations.
Who is sponsoring the NCT06192979 clinical trial?
NCT06192979 is sponsored by Jin Lu, MD. The principal investigator is Jin Lu at Peking University People's Hospital. The trial plans to enroll 41 participants.