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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma, Extranodal NK-T-Cell

Intervention / Treatment
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* Drug: gemcitabine
* Drug: oxaliplatin
* Drug: pegaspargase


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-Gemox<br>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<br>* gemcitabine :1250mg/m2 (ivdrip) on days 1<br>* Other names: Gemzar;Drug: oxaliplatin<br>* oxaliplatin :85 mg/m2 (ivdrip) on day 1<br>* Other names: Eloxatin;Drug: pegaspargase<br>* pegaspargase : 2500 IU/m2 (intramuscular injection)<br>* Other names: Oncaspar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | every 4 weeks,up to completion of treatment(approximately 6 months) | 
| 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 | up to end of follow-up-phase (approximately 3 years) | 
| 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) | up to end of follow-up-phase (approximately 3 years) | 
| serum soluble programmed death ligand 1 | Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay | every 3 weeks,up to completion of treatment(approximately 6 months) | 
| serum interleukin 15 | serum interleukin 15 is measured using an enzyme-linked immunosorbent assay | every 3 weeks,up to completion of treatment(approximately 6 months) | 
| Serum ferritin level | Serum ferritin level is measured using radioimmunoassay | every 3 weeks,up to completion of treatment(approximately 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK/T-cell lymphoma, induction chemotherapy, survival