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A Study to Evaluate the Efficacy and Safety of Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in the Refractory or Relapsed PTCL: A Phase 2, Single-center, Single-arm, Open Label Trial

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A Study to Evaluate the Efficacy and Safety of Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in the Refractory or Relapsed PTCL: A Phase 2, Single-center, Single-arm, Open Label Trial

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Azacitidine (Primary) ; Sintilimab (Primary) ; Tucidinostat (Primary)
  • Indications Peripheral T-cell lymphoma
  • Focus Therapeutic Use

    • Most Recent Events

    • 05 Mar 2021 Treatments section is updated to include two new experimental drugs namely- chidamide and azacytidine. Inclusion criteria is updated to remove Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Primary Central Nervous System Lymphoma (PCNSL) and Peripheral NK- cell Lymphoma (PNKCL) and include only Peripheral-T-cell-lymphoma (PTCL) patients. Inclusion age limit is also increased from 70 to 80 years. ECOG Performance Status limit increased from 0-1 to 0-2.
    • 05 Mar 2021 Status changed from recruiting to not yet recruiting.
    • 05 Mar 2021 Planned End Date changed from 7 May 2023 to 30 Dec 2025.

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