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

StatusRecruiting
PhaseNot applicable
SponsorJin Lu, MD
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 7, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study sites: 6 to 7v4
  2. Notable Primary completion date: Dec 31, 2025 to Sep 30, 2026
    • Study sites: 1 to 6
    • Study completion date: Jun 30, 2026 to Mar 31, 2027
    v3
  3. Minor Start date changed from estimate of Dec 31, 2023 to Jan 5, 2024v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
330 trials monitored
See 20 trials at risk
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.
Trial Details
NCT Number NCT06192979
Lead Sponsor Jin Lu, MD
Conditions
(from sponsor)
Amyloidosis; Systemic, AL Amyloidosis
Related terms Immunoglobulin Light-chain Amyloidosis
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov