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

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.

Study Overview

• Status: Recruiting
• Conditions: NK/T Cell Lymphoma Nos
• Intervention / Treatment: Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Zhu, Dr.; Phone Number: +86-13910333346; Email: zhu-jun@bjcancer.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage I/II nasal ENKTL; 2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation	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.
Experimental: Stage III/IV or primary extra-nasal ENKTL; 6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete response rate	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University Cancer Hospital & Institute; Peking University International Hospital; Jiangxi Provincial Cancer Hospital; Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2011
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Cyclophosphamide; Etoposide; Prednisone; Vincristine; Pegaspargase
• Other Study ID Numbers: COEPL for NKTCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No