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

NK/T Cell Lymphoma Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484506
• Other study ID #: COEPL for NKTCL
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2011
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2020
• Source: Peking University
• Contact: Jun Zhu, Dr.
• Phone: +86-13910333346
• Email: zhu-jun[@]bjcancer.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• NK/T Cell Lymphoma Nos

Intervention

Drug:
• pegaspargase, 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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking University	Beijing Cancer Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		1 year
Secondary	Overall response rate		1 year
Secondary	Progression-free survival		3-year
Secondary	Overall survival		3-year
Secondary	Adverse events		1-year