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Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Recruiting
18 years and older
All
Phase 2

Overview

This prospectivemulti-centeropen-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Description

Peripheral T-cell lymphoma (PTCLis a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. There is no standard of care for those patients. Targeted drugs are warranted in this group of patients to improve survival. This prospectivemulti-centeropen-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Eligibility

Inclusion Criteria:

  • Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification with enough tumor sample for NGS
  • Treatment naive
  • Age 18 years
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • ECOG 0,1,2
  • Informed consented

Exclusion Criteria:

  • ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
  • Has accepted localized or systemic anti-lymphoma treatment
  • Has accepted autologous Stem cell transplantation before
  • History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary CNS lymphoma
  • Left EF 50%
  • Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.510^9/ L ;Platelet<5010^9/L; ALT or AST >2ULN; Creatinine>1.5ULN
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • Not able to comply to the protocol for mental or other unknown reasons
  • Patients with mentally disorders or other reasons unable to fully comply with the study protocol
  • Pregnant or lactation
  • HIV infection
  • HBV-DNA or HCV-RNA positive

Study details
    Peripheral T-Cell Lymphoma
    T-Cell Lymphoma
    T-Cell Lymphoma

NCT04480099

Ruijin Hospital

5 August 2020

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