Evaluating Pegaspargase with Chemoradiotherapy for Early Stage Extranodal NK/T-cell Lymphoma
Evaluate the Safety and Efficacy of Pegaspargase-based Concurrent Chemoradiotherapy in the Treatment of Early Stage Extranodal NK/T Cell Lymphoma
This study is testing if adding a drug called pegaspargase to standard radiation therapy can help people with early-stage extranodal NK/T-cell lymphoma feel better and manage their disease more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06406556 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of concurrent chemoradiotherapy using pegaspargase in patients diagnosed with early-stage extranodal NK/T-cell lymphoma (ENKTL). Participants will receive a treatment regimen that includes involved field radiotherapy and two cycles of pegaspargase, followed by additional cycles of the drug. The study will monitor the efficacy of this approach in managing the disease while also evaluating any associated toxicities. The trial is designed as a multi-center, single-arm phase II study to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18-75 with a confirmed diagnosis of early-stage ENKTL who have not received prior treatment.
Not a fit: Patients with symptomatic CNS involvement or those with other concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with early-stage ENKTL, potentially improving survival rates and quality of life.
How similar studies have performed: While there have been studies on chemoradiotherapy for lymphoma, the specific use of pegaspargase in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.The patient was pathologically diagnosed as ENKTL and had not received any previous treatment for ENKTL;2.The estimated survival time ≥ 3 months. 3.18-75 years old ; 4. Ann-Arbor stage was IE-IIE ; 5. ECOG performance status 0-2 ; 6.Clinicians judged that patients were suitable for concurrent chemoradiotherapy ; 7.No radiotherapy or hormone drugs were received within 4 weeks before treatment;8.After the patients were enrolled in the trial, they could not accept other drugs that may have therapeutic effects on ENKTL ; 9.WBC≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ; 10.Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ; 11.ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ; 12.Serum fibrinogen level ≥ 1.0g / L ; 13.Signed informed consent form. Exclusion Criteria:1.Symptomatic CNS involvement, previous or current accompanied by other malignant tumors ; 2.The primary lesion is ENKTL from non-upper respiratory gastrointestinal tract ; 3.Patients with poor general condition, ECOG performance status \>2 ; 4.Women in pregnancy or lactation; 5.The patient ( male or female ) has the possibility of fertility but is unwilling or does not take effective contraceptive measures; 6. Known allergies to test drugs or any excipient component of these products ;7.Doctors believe that patients are not suitable for concurrent chemoradiotherapy; 8.Active infection ( determined by the researcher ) ; 9.According to the researchers ' judgment, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;10. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
Where this trial is running
Guangzhou, Guangdong
- HuaWang — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hua Wang, MD — Sun Yat-senU
- Study coordinator: Hua Wang, MD
- Email: wanghua@sysucc.org.cn
- Phone: 15920352412
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.