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

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborators: Beijing Cancer Hospital; Hebei Medical University Fourth Hospital; Jiangxi Provincial Cancer Hospital; Peking University International Hospital
• Treatments: Cyclophosphamide; Etoposide; Pegaspargase; Prednisone; Vincristine

Criteria

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