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

Primary Purpose

NK/T Cell Lymphoma Nos

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

About this trial

This is an interventional treatment trial for NK/T Cell Lymphoma Nos

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Peking University Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Stage I/II nasal ENKTL

Stage III/IV or primary extra-nasal ENKTL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

Overall response rate

Progression-free survival

Overall survival

Adverse events

Full Information

NCT ID

NCT04484506

First Posted

July 20, 2020

Last Updated

July 20, 2020

Sponsor

Peking University

Collaborators

Peking University Cancer Hospital & Institute, Peking University International Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04484506

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2011 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

Peking University Cancer Hospital & Institute, Peking University International Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NK/T Cell Lymphoma Nos

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stage I/II nasal ENKTL

Arm Type

Experimental

Arm Description

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

Arm Title

Stage III/IV or primary extra-nasal ENKTL

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone

Intervention Description

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.

Primary Outcome Measure Information:

Title

Complete response rate

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate

Time Frame

1 year

Title

Progression-free survival

Time Frame

3-year

Title

Overall survival

Time Frame

3-year

Title

Adverse events

Time Frame

1-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhu, Dr.

Phone

+86-13910333346

zhu-jun@bjcancer.org

Facility Information:

Facility Name

Peking University Cancer Hospital & Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhu

zj@bjcancer.org

First Name & Middle Initial & Last Name & Degree

Yuqin Song

songyuqin622@sina.com

First Name & Middle Initial & Last Name & Degree

Yuqin Song

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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