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

Status Terminated

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02533323
Study type	Interventional
Source	Sun Yat-sen University
Contact
Status	Terminated
Phase	Phase 2
Start date	January 2012
Completion date	January 2017

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT02878278` - Differences Between Chidamide Taken Daily and Twice a Week in Therapeutic Effect，Pharmacokinetics, Pharmacodynamics and EB Virus Activation	Phase 2
Terminated	`NCT01948180` - Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma	Phase 2
Completed	`NCT00069238` - Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas	Phase 2
Recruiting	`NCT03646422` - AEDV Registry of Primary Cutaneous Lymphoma
Terminated	`NCT02359162` - Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage	Phase 3
Recruiting	`NCT02080234` - Combine GELOX With Concurrent Radiation Therapy for Patients With Stage IE/IIE ENKTL	Phase 2
Completed	`NCT03049449` - T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas	Phase 1
Not yet recruiting	`NCT03051542` - Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Natural Killer/T-cell Lymphoma	N/A
Not yet recruiting	`NCT03051555` - 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma	N/A
Recruiting	`NCT03154918` - GLIDE Regimen Followed by ASCT for Aggressive NK/T Cell Lymphoma	Phase 2
Recruiting	`NCT01933282` - MESA Treatment for NK/T Cell Lymphoma	Phase 2
Active, not recruiting	`NCT03439501` - Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma[AVENT STUDY]	Phase 2
Recruiting	`NCT04417166` - Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma	Phase 2
Recruiting	`NCT02859402` - Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas	Phase 2