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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Terminated

CT.gov ID

NCT02533323

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Extranodal NK-T-Cell	Drug: gemcitabine Drug: oxaliplatin Drug: pegaspargase	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: P-Gemox 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: gemcitabine gemcitabine :1250mg/m2 (ivdrip) on days 1 Other Names: Gemzar Drug: oxaliplatin oxaliplatin :85 mg/m2 (ivdrip) on day 1 Other Names: Eloxatin Drug: pegaspargase pegaspargase : 2500 IU/m2 (intramuscular injection) Other Names: Oncaspar

Arm

Intervention/Treatment

Experimental: P-Gemox

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: gemcitabine

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

Other Names:

Gemzar

Drug: oxaliplatin

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

Other Names:

Eloxatin

Drug: pegaspargase

pegaspargase : 2500 IU/m2 (intramuscular injection)

Other Names:

Oncaspar

Outcome Measures

Primary Outcome Measures

progression free survival [up to end of follow-up-phase (approximately 3 years)]
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 [every 4 weeks,up to completion of treatment(approximately 6 months)]
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 [up to end of follow-up-phase (approximately 3 years)]
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 [up to end of follow-up-phase (approximately 3 years)]
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 [every 3 weeks,up to completion of treatment(approximately 6 months)]
Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay
serum interleukin 15 [every 3 weeks,up to completion of treatment(approximately 6 months)]
serum interleukin 15 is measured using an enzyme-linked immunosorbent assay
Serum ferritin level [every 3 weeks,up to completion of treatment(approximately 6 months)]
Serum ferritin level is measured using radioimmunoassay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.