NCT04484506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2011

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

12.2 years

First QC Date

July 20, 2020

Last Update Submit

July 20, 2020

Conditions

NK/T Cell Lymphoma Nos

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    1 year

Secondary Outcomes (4)

  • Overall response rate

    1 year

  • Progression-free survival

    3-year

  • Overall survival

    3-year

  • Adverse events

    1-year

Study Arms (2)

Stage I/II nasal ENKTL

EXPERIMENTAL

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

Stage III/IV or primary extra-nasal ENKTL

EXPERIMENTAL

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

Interventions

pegaspargase, cyclophosphamide, vincristine, etoposide, prednisoneDRUG

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.

Stage I/II nasal ENKTLStage III/IV or primary extra-nasal ENKTL

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

pegaspargaseCyclophosphamideVincristineEtoposidePrednisone

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Central Study Contacts

Jun Zhu, Dr.

CONTACT

+86-13910333346zhu-jun@bjcancer.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

October 20, 2011

Primary Completion

December 30, 2023

Study Completion

December 30, 2025

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)