Combining chemotherapy and radiation for early-stage NK/T-cell lymphoma treatment
A Multicenter, Randomized, Controlled Phase II Screening Study of Combined Sequential Chemotherapy and Radiation Therapies for Early-stage Natural Killer/T-cell Lymphoma (IE/IIE)
This study is testing three different treatment plans for early-stage NK/T-cell lymphoma to see which one helps patients live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Sintilimab |
| Locations | 7 sites (Fuzhou, Fujian and 6 other locations) |
| Trial ID | NCT06314334 on ClinicalTrials.gov |
What this trial studies
This study evaluates three treatment strategies for early-stage natural killer/T-cell lymphoma (NKTCL), a common and aggressive cancer in East Asian populations. Patients will be randomly assigned to receive either a combination of Pegaspargase and Sintilimab with radiotherapy, a chemotherapy regimen followed by radiotherapy, or a sandwich approach of chemoradiotherapy. The primary goal is to determine which strategy offers the best progression-free survival over 24 months. The study aims to clarify the optimal sequencing of treatments and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed early-stage NKTCL and no prior treatment for the disease.
Not a fit: Patients with advanced-stage NKTCL 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 lead to more effective treatment options for patients with early-stage NKTCL, potentially improving survival rates.
How similar studies have performed: While there have been studies on NKTCL treatments, this specific comparison of treatment strategies is novel and has not been previously tested in a prospective randomized controlled format.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination. * Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE/IIE based on PET/CT and bone marrow examination according to the Lugano 2014 criteria. * Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET/CT. * No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma. * Age between 18 and 75 years, both genders. * Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2. * Must have adequate organ and bone marrow function, defined as follows: Hematology: Absolute neutrophil count (ANC) ≥1.0×10\^9/L, platelet count (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥90g/L; no administration of granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion in the previous 14 days. Liver function: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN. Renal function: Serum creatinine (Cr) ≤1.5×ULN. Coagulation function: Plasma fibrinogen ≥1.5g/L. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no acute myocardial infarction, arrhythmia, or atrioventricular conduction block of grade I or above on electrocardiogram. * Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations. Exclusion Criteria: * Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA \>10\^3/ml. * Patients with a history of pancreatitis. * Patients with acute or systemic infections requiring intravenous antibiotic therapy. * Patients with severe complications such as hemophagocytic syndrome, DIC, etc. * Significant organ dysfunction: such as respiratory failure, chronic congestive heart failure with NYHA class ≥2, decompensated liver or renal dysfunction, uncontrolled hypertension and diabetes despite aggressive treatment, and cardiovascular thrombotic or hemorrhagic events in the past 6 months. * Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors. * Pregnant and lactating women. * Patients with psychiatric disorders. * Known allergies to drugs in the chemotherapy regimen. * Patients with concomitant other tumors requiring surgery or chemotherapy within the past 6 months. * Currently using other experimental drugs.
Where this trial is running
Fuzhou, Fujian and 6 other locations
- Cancer Hospital of Fujian Province — Fuzhou, Fujian, China (Recruiting)
- Nantong Cancer Hospital — Nantong, Jiangsu, China (Recruiting)
- Shanghai Eye Ear Nose and Throat Hospital，Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Rong Tao, MD
- Email: rtao@shca.org.cn
- Phone: 8621-64175590
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.