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

Lymphoma, Extranodal NK-T-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02533323
• Other study ID #: SYSUCC-NK/T-5010
• Status: Terminated
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell

Intervention

Drug:
• gemcitabine
gemcitabine :1250mg/m2 (ivdrip) on days 1
• oxaliplatin
oxaliplatin :85 mg/m2 (ivdrip) on day 1
• pegaspargase
pegaspargase : 2500 IU/m2 (intramuscular injection)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Serum ferritin level	Serum ferritin level is measured using radioimmunoassay	every 3 weeks,up to completion of treatment(approximately 6 months)