NCT02533323

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Lymphoma, Extranodal NK-T-Cell

Interventions

Type	Name	Description
DRUG	gemcitabine	gemcitabine :1250mg/m2 (ivdrip) on days 1
DRUG	oxaliplatin	oxaliplatin :85 mg/m2 (ivdrip) on day 1
DRUG	pegaspargase	pegaspargase : 2500 IU/m2 (intramuscular injection)

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2015-08-26
• Last updated: 2018-05-09

Locations

1 site across 1 country: China