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New treatment option for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Official title Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
ClinicalTrials.gov ID: NCT06314334
What this study is testing
What is Sintilimab+Pegaspargase?
Sintilimab+Pegaspargase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for natural killer/t-cell lymphoma, nasal and nasal-type.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors.
See the full eligibility 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...
- 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...
- Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Nantong, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Nantong, Jiangsu, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.