Clinical trial · Interventional
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
NCT02533323CI-TRIAL-00032841terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Extranodal NK-T-Cell | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- P-Gemox
- description
- 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.
- interventionNames
- Drug: gemcitabine
- Drug: oxaliplatin
- Drug: pegaspargase
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- up to end of follow-up-phase (approximately 3 years)
- description
- 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
Secondary outcomes (6)
- measure
- complete remission rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.