Treatment for advanced NK/T-cell lymphoma using Sintilimab and P-GemOx regimen
Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study
PHASE2 · Sun Yat-sen University · NCT04127227
This study is testing a new treatment combining Sintilimab with a specific drug regimen to see if it helps people who have just been diagnosed with advanced NK/T-cell lymphoma feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, immunotherapy, Sintilimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04127227 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Sintilimab combined with the P-GemOx regimen, which includes pegaspargase, gemcitabine, and oxaliplatin, for patients newly diagnosed with advanced extranodal natural killer/T-cell lymphoma, nasal type. It is a multi-center, single-arm, phase 2 trial aimed at determining how well this treatment works in managing the disease. Participants must have a confirmed diagnosis and meet specific health criteria to be eligible for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed stage III/IV extranodal natural killer/T-cell lymphoma and at least one evaluable lesion.
Not a fit: Patients with central nervous system involvement or those who have received prior treatment for lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced NK/T-cell lymphoma.
How similar studies have performed: While similar approaches have been explored, this specific combination of Sintilimab with P-GemOx for this type of lymphoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; * newly diagnosed stage III/IV 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
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — 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