Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma

Overview

The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.

Full Title of Study: “A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2023

Interventions

  • Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
    • Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.

Arms, Groups and Cohorts

  • Experimental: Stage I/II nasal ENKTL
    • 2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
  • Experimental: Stage III/IV or primary extra-nasal ENKTL
    • 6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation

Clinical Trial Outcome Measures

Primary Measures

  • Complete response rate
    • Time Frame: 1 year

Secondary Measures

  • Overall response rate
    • Time Frame: 1 year
  • Progression-free survival
    • Time Frame: 3-year
  • Overall survival
    • Time Frame: 3-year
  • Adverse events
    • Time Frame: 1-year

Participating in This Clinical Trial

Inclusion Criteria

  • patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria – age 14-80 years – no prior chemotherapy or radiotherapy – Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 – at least one measurable lesion – adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10^9/L, platelets ≥ 100 ×10^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal) – expected survival of more than three months Exclusion Criteria:

  • invasion of lymphoma to central nervous system – pre-existing coagulation disorder – other concomitant neoplasms – severe infection – positive HIV antibody – HBV DNA titer higher than 10^4 copies /ml in HBsAg-positive patients post antiviral therapy – pregnant or lactating women – women of childbearing age unwilling to take contraceptive measures during the study period

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University
  • Collaborator
    • Beijing Cancer Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Zhu, Dr. – Beijing Cancer Hospital
  • Overall Contact(s)
    • Jun Zhu, Dr., +86-13910333346, zhu-jun@bjcancer.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.