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A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma

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A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma

Status: Suspended
Phase of Trial: Phase II/III

Latest Information Update: 14 Jun 2021

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At a glance

  • Drugs Masitinib (Primary) ; Dexamethasone; Gemcitabine
  • Indications Peripheral T-cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science

    • Most Recent Events

    • 08 Jun 2021 According to an AB Science media release, the company consulted with external experts and decided to perform a series of analysis called meta-analysis on all available data from controlled and unblinded study data.
    • 08 Jun 2021 Status changed from active, no longer recruiting to suspended, according to an AB Science media release.
    • 08 Jun 2021 According to an AB Science media release, the company decides to voluntarily put a temporary hold on recruitment and randomization to protect patient's safety and because of a potential signal of ischemic heart disease. Studies continue for patients already under treatment subject to documentation by the investigator of the individual benefit/risk. Patients continue to be dosed.

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