NCT02533323

Brief Summary

This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

October 1, 2016

Enrollment Period

4.7 years

First QC Date

August 24, 2015

Last Update Submit

May 8, 2018

Conditions

Lymphoma, Extranodal NK-T-Cell

Keywords

NK/T-cell lymphomainduction chemotherapysurvival

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first

    up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes (6)

  • complete remission rate

    every 4 weeks,up to completion of treatment(approximately 6 months)

  • overall survival

    up to end of follow-up-phase (approximately 3 years)

  • safety, as measured by adverse events

    up to end of follow-up-phase (approximately 3 years)

  • serum soluble programmed death ligand 1

    every 3 weeks,up to completion of treatment(approximately 6 months)

  • serum interleukin 15

    every 3 weeks,up to completion of treatment(approximately 6 months)

  • +1 more secondary outcomes

Study Arms (1)

P-Gemox

EXPERIMENTAL

P-Gemox:gemcitabine :1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days.

Drug: gemcitabineDrug: oxaliplatinDrug: pegaspargase

Interventions

gemcitabineDRUG

gemcitabine :1250mg/m2 (ivdrip) on days 1

Also known as: Gemzar
P-Gemox
oxaliplatinDRUG

oxaliplatin :85 mg/m2 (ivdrip) on day 1

Also known as: Eloxatin
P-Gemox
pegaspargaseDRUG

pegaspargase : 2500 IU/m2 (intramuscular injection)

Also known as: Oncaspar
P-Gemox

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed ENKTL
  • age:18-80years
  • at lease one measurable lesion
  • receive no chemotherapy or radiotherapy before
  • Eastern CooperativeOncology Group performance status of 0 to 2.
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

You may not qualify if:

  • systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

GemcitabineOxaliplatinpegaspargase

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • yue lu, MD.

    Department of Hematological Oncology, Sun Yat-sen University Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 26, 2015

Study Start

January 1, 2012

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

May 9, 2018

Record last verified: 2016-10

Locations

CN(1)