A Phase 2 interventional study of gemcitabine and oxaliplatin in Lymphoma, Extranodal NK-T-Cell, sponsored by Sun Yat-sen University. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
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 · Drug: oxaliplatin · Drug: pegaspargase
gemcitabine :1250mg/m2 (ivdrip) on days 1
Also known as: Gemzar
oxaliplatin :85 mg/m2 (ivdrip) on day 1
Also known as: Eloxatin
pegaspargase : 2500 IU/m2 (intramuscular injection)
Also known as: Oncaspar
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)
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)
Serum ferritin level
Serum ferritin level is measured using radioimmunoassay
Time frame: every 3 weeks,up to completion of treatment(approximately 6 months)
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University