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

Phase 2TerminatedNCT02533323

Sun Yat-sen University50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

gemcitabineDRUG

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

oxaliplatinDRUG

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

pegaspargaseDRUG

pegaspargase : 2500 IU/m2 (intramuscular injection)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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