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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04484506

Enrollment

150

Registered

2020-07-23

Start date

2011-10-20

Completion date

2025-12-30

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NK/T Cell Lymphoma Nos

Brief 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.

Interventions

DRUGpegaspargase, 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete response rate	1 year

Secondary

Measure	Time frame
Overall response rate	1 year
Progression-free survival	3-year
Overall survival	3-year
Adverse events	1-year

Countries

China

Contacts

Primary ContactJun Zhu, Dr.

zhu-jun@bjcancer.org+86-13910333346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026