Optimize First-line Treatment for AL Amyloidosis With t (11; 14) (NCT06192979) | Clinical Trial Compass
RecruitingNot Applicable
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
China41 participantsStarted 2024-01-05
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;