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

Peking University

Status and phase: Enrolling; Phase 2

Conditions: NK/T Cell Lymphoma Nos

Treatments: Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT04484506

COEPL for NKTCL

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Stage I/II nasal ENKTL

Experimental group

Description:

2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation

Treatment:

Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

Stage III/IV or primary extra-nasal ENKTL

Experimental group

Description:

6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation

Treatment:

Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone