Clinical trial · Interventional
Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma
A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma
NCT04484506CI-TRIAL-00046129unknownPhase 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)
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.
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 |
|---|---|---|---|
| NK/T Cell Lymphoma Nos | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stage I/II nasal ENKTL
- description
- 2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
- interventionNames
- Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
- type
- EXPERIMENTAL
- label
- Stage III/IV or primary extra-nasal ENKTL
- description
- 6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation
- interventionNames
- Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria * age 14-80 years * no prior chemotherapy or radiotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * at least one measurable lesion * adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelets ≥ 100 ×10\^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal) * expected survival of more than three months Exclusion Criteria: * invasion of lymphoma to central nervous system * pre-existing coagulation disorder * other concomitant neoplasms * severe infection * positive HIV antibody * HBV DNA titer higher than 10\^4 copies /ml in HBsAg-positive patients post antiviral therapy * pregnant or lactating women * women of childbearing age unwilling to take contraceptive measures during the study period
References
Publications (0)
Data not yet available
No reference posted for this study.