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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    150
  • sponsor
    Peking University
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Updated on 19 February 2024
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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.

Details
Condition NK/T Cell Lymphoma Nos
Age 14years - 80years
Treatment pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
Clinical Study IdentifierNCT04484506
SponsorPeking University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 mol/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
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