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P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

Primary Purpose

Lymphoma, Extranodal NK-T-Cell

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

gemcitabine

oxaliplatin

pegaspargase

About this trial

This is an interventional treatment trial for Lymphoma, Extranodal NK-T-Cell focused on measuring NK/T-cell lymphoma, induction chemotherapy, survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

P-Gemox

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

complete remission rate

The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244.

overall survival

overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first

safety, as measured by adverse events

ncluding hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

serum soluble programmed death ligand 1

Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay

serum interleukin 15

serum interleukin 15 is measured using an enzyme-linked immunosorbent assay

Serum ferritin level

Serum ferritin level is measured using radioimmunoassay

Full Information

NCT ID

NCT02533323

First Posted

August 24, 2015

Last Updated

May 8, 2018

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02533323

Brief Title

P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

Official Title

Phase 2 Trial of Pegaspargase-Gemox Chemotherapy in Newly Diagnosed, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. Stage IIIE/IVE patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

6. Conditions and Keywords

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

Lymphoma, Extranodal NK-T-Cell

Keywords

NK/T-cell lymphoma, induction chemotherapy, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P-Gemox

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

pegaspargase

Other Intervention Name(s)

Oncaspar

Intervention Description

pegaspargase : 2500 IU/m2 (intramuscular injection)

Primary Outcome Measure Information:

Title

progression free survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

complete remission rate

Description

Time Frame

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

Title

overall survival

Description

overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first

Time Frame

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

Title

safety, as measured by adverse events

Description

ncluding hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Time Frame

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

Title

serum soluble programmed death ligand 1

Description

Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay

Time Frame

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

Title

serum interleukin 15

Description

serum interleukin 15 is measured using an enzyme-linked immunosorbent assay

Time Frame

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

Title

Serum ferritin level

Description

Serum ferritin level is measured using radioimmunoassay

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: mismatch the inclusion criteria systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yue lu, MD.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

GuangZhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

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P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

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