Treatment for aggressive natural killer/T-cell lymphoma
Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma
This study is testing a new combination treatment for people with aggressive natural killer/T-cell lymphoma to see if it helps them respond better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Please Select) |
| Trial ID | NCT02705508 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the efficacy and safety of a combination treatment involving pegylated aspargase, etoposide, and gemcitabine for patients with extranodal natural killer/T-cell lymphoma (ENKTL). The treatment regimen includes intravenous infusions of gemcitabine and etoposide, along with deep intramuscular injections of pegylated aspargase, administered in cycles every three weeks. Patients with advanced stages may also receive involved-field radiotherapy following chemotherapy. The study aims to assess the response rates and overall survival in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed, previously untreated or refractory/relapsed ENKTL.
Not a fit: Patients with severe comorbidities or those who have not completed prior chemotherapy and radiotherapy within the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with ENKTL.
How similar studies have performed: Other studies have shown promise with similar chemotherapy regimens in treating aggressive lymphomas, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; 2. age≥18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. Prior chemotherapy and radiotherapy should have been completed \>4 weeks 10.earlier,willingness to provide written informed consent. Exclusion Criteria: -
Where this trial is running
Guangzhou, Please Select
- Sun Yat-sen University Cancer Center — Guangzhou, Please Select, China (Recruiting)
Study contacts
- Principal investigator: hua wang, MD. — Sun Yat-sen University
- Study coordinator: hua wang, MD.
- Email: wanghua@sysucc.org.cn
- Phone: 0086-02087342462
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.