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Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

RecruitingNAAges any - anyAllJin Lu, MD
NCT06192979 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Daratumumab
  • Bortezomib
  • Dexamethasone
  • Venetoclax
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Where

7 sites
Peking University People's Hospital
Beijing, China
Capital Medical University Affiliated Fuxing Hospital
Beijing, China
Beijing Anzhen Hospital
Beijing, China
Chinese PLA Eastern Theater General Hospital
Nanjing, China
Qilu Hospital of Shandong University (QingDao)
Qingdao, China
Qingdao Municipal Hospital
Qingdao, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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