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NCT03401372

BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients

Completed NA Last updated 23 February 2021
What this trial tests

NA trial testing Doxycycline in Amyloidosis; Systemic in 140 participants. Completed in 31 December 2020.

Timeline
21 April 2018
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorJian Li
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment140
Start date21 April 2018
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jian Li

Who can join

18 and older, any sex, with Amyloidosis; Systemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Survival of intermediate and high-risk primary light chain amyloidosis (pAL) remains poor due to high mortality within 3-6 months of diagnosis. Rapidly effective regimens such as bortezomib, cyclophosphamide and dexamethasone (BCD) still failed to overcome the poor prognosis in very advanced pAL amyloidosis patients. Recently, doxycycline was demonstrated to induce disruption of fibril formation and reduce the number of intact fibrils in transgenic mouse model of pAL amyloidosis. Furthermore, case-control study suggested that adjuvant oral doxycycline could improve response and survival in cardiac pAL amyloidosis, which necessities further confirmation through a randomized trial. Therefore, we designed a multi-center randomized open-label controlled study to investigate the efficacy and safety of co-administration of oral doxycycline with BCD regimen in treatment-naïve patients with Mayo stage II-III pAL amyloidosis. The primary outcome progression-free survival, and secondary endpoints including overall survival, hematologic response, organ response and toxicity of doxycycline will be evaluated.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advances in the Treatment of Cardiac Amyloidosis.
    Macedo AVS, Schwartzmann PV, de Gusmão BM, Melo MDT, et al · · 2020 · cited 40× · PMID 32328845 · DOI 10.1007/s11864-020-00738-8
  2. Emerging Therapeutics for the Treatment of Light Chain and Transthyretin Amyloidosis.
    Zhang KW, Stockerl-Goldstein KE, Lenihan DJ. · · 2019 · cited 35× · PMID 31312767 · DOI 10.1016/j.jacbts.2019.02.002
  3. Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial.
    Shen KN, Fu WJ, Wu Y, Dong YJ, et al · · 2022 · cited 29× · PMID 34503349 · DOI 10.1161/circulationaha.121.055953
  4. Doxycycline decreases amyloidogenic light chain-induced autophagy in isolated primary cardiac myocytes.
    Valero-Muñoz M, Wilson RM, Bretón-Romero R, Croteau D, et al · · 2020 · cited 11× · PMID 32682005 · DOI 10.1016/j.ijcard.2020.07.016
  5. Emerging Pharmacological Strategies for Cardiac Amyloidosis: A Qualitative Analysis of Interventional Clinical Trials Registered on ClinicalTrials.Gov
    Harbi M, Alzahrani Y. · · 2026

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Other trials of Doxycycline

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