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

Last updated: March 6, 2026
Sponsor: Jin Lu, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Treatment

Daratumumab

Dexamethasone

Venetoclax

Clinical Study ID

NCT06192979
2023PHB319-001
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacyticlymphoma.

  2. Presence of other tumors which is/are in advanced malignant stage and has/havesystemic 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 subjector affect the results of the study.

Study Design

Total Participants: 41
Treatment Group(s): 4
Primary Treatment: Daratumumab
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
March 31, 2027

Study Description

The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.

Connect with a study center

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality 101118
    China

    Active - Recruiting

  • Capital Medical University Affiliated Fuxing Hospital

    Beijing, Beijing Municipality 100045
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality 100044
    China

    Active - Recruiting

  • Chinese PLA Eastern Theater General Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266011
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi 710061
    China

    Active - Recruiting

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