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

Last updated: July 20, 2020
Sponsor: Peking University
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04484506
COEPL for NKTCL
  • Ages 14-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 upperlimit of normal, and ALT /AST ≤2.5 times the upper limit of normal)

  • expected survival of more than three months

Exclusion

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 antiviraltherapy

  • pregnant or lactating women

  • women of childbearing age unwilling to take contraceptive measures during the studyperiod

Study Design

Total Participants: 150
Study Start date:
October 20, 2011
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing 100142
    China

    Active - Recruiting

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