Combining Pegaspargase and Chemotherapy with Radiotherapy for 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
This study is testing a new treatment plan that combines chemotherapy and radiation for people who have just been diagnosed with extra-nodal NK/T-cell lymphoma to see if it works better than existing options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, prednisone |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04484506 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the effectiveness and safety of a treatment regimen that includes pegaspargase, cyclophosphamide, vincristine, etoposide, and prednisone (COEPL) combined with radiotherapy for patients newly diagnosed with extra-nodal NK/T-cell lymphoma (ENKTL). The study aims to establish a more defined first-line treatment approach for this type of lymphoma, which currently lacks a well-defined standard. Participants will be monitored for treatment efficacy and safety throughout the study.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14-80 with a confirmed diagnosis of ENKTL and no prior chemotherapy or radiotherapy.
Not a fit: Patients with central nervous system involvement, severe infections, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line therapy for patients with extra-nodal NK/T-cell lymphoma.
How similar studies have performed: While this approach is being evaluated in this study, the combination of chemotherapy and radiotherapy has shown promise in other lymphoma treatments, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Peking University Cancer Hospital & Institute — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jun Zhu, Dr.
- Email: zhu-jun@bjcancer.org
- Phone: +86-13910333346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.