Comparing treatments for early-stage NK/T cell lymphoma
A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
PHASE3 · Sun Yat-sen University · NCT04365036
This study is testing whether adding a new antibody treatment to the standard therapy helps people with early-stage NK/T cell lymphoma do better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 207 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, immunotherapy, toripalimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04365036 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of sequential chemoradiotherapy with or without the PD-1 antibody, toripalimab, in patients with newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type. It is a multicenter, phase 3 randomized trial that will involve multiple treatment centers. Participants will receive either the standard treatment or the treatment combined with toripalimab to determine which approach yields better outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma, nasal type.
Not a fit: Patients with aggressive NK cell leukemia or those who have previously received treatment for lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with early-stage NK/T cell lymphoma.
How similar studies have performed: Other studies have shown promise in using PD-1 antibodies in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; * newly diagnosed stage I/II patients; * at least one evaluable lesion； * ECOG PS 0-2; * 18-75 years; without other malignancy; * proper functioning of the major organs. Exclusion Criteria: * hemophagocytic syndrome or aggressive NK cell leukemia; * involvement of central nervous system; * previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Where this trial is running
Guangzhou, Guangdong
- Guangdong General Hospital — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Qingqing Cai, MD
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
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.
Conditions: NK/T Cell Lymphoma Nos