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

Phase 2

Recruiting

• Conditions: NK/T Cell Lymphoma Nos
• Interventions: Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

• Registration Number: NCT04484506
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-20
• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2023-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stage I/II nasal ENKTL	pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone	2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
Stage III/IV or primary extra-nasal ENKTL	pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone	6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Complete response rate	1 year

Secondary Outcome Measures

Name	Time	Method
Overall response rate	1 year
Progression-free survival	3-year
Overall survival	3-year
Adverse events	1-year

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Beijing, China