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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: progression free survival [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • complete remission rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    Serum ferritin level is measured using radioimmunoassay


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: August 24, 2015
Date Started: January 2012
Date Completion: June 2018
Last Updated: October 19, 2016
Last Verified: October 2016