Actively Recruiting
A Single-arm Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin for Newly Diagnosed Extranodal NK/T-Cell Lymphoma
Led by Peking Union Medical College Hospital · Updated on 2025-02-13
49
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment combining sintilimab, pegaspargase, gemcitabine, and oxaliplatin (called the P-P-GEMOX regimen) as a first treatment for patients newly diagnosed with extranodal NK/T-cell lymphoma (ENKTL). This phase 2 study aims to measure the complete response rate after treatment. Secondary goals include overall response rate, progression-free survival, overall survival, and monitoring of side effects. Patients receive the P-P-GEMOX regimen every three weeks. Those with early-stage disease (stage I-II) first get two cycles of treatment, followed by radiotherapy if they respond, and then two more cycles afterward. Patients with advanced disease (stage III-IV) receive six cycles of treatment. If they respond well, further options such as stem cell transplantation or maintenance therapy with PD-1 monoclonal antibody may be considered based on age and physical condition. Participants will be closely monitored with evaluations after three treatment cycles and one month after finishing therapy to determine response. Safety is assessed through tracking adverse events during treatment and for 28 days after the last cycle. Progression-free survival and overall survival will be followed for up to three years from enrollment to understand longer-term outcomes. The study is sponsored by Peking Union Medical College Hospital and runs until May 2027.
CONDITIONS
Brief Title
Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center.
- Age between 18 and 75 years.
- At least one of the following risk factors: age 60 years or older, presence of B symptoms, ECOG performance status 2 or higher, elevated lactate dehydrogenase (LDH), baseline EBV-DNA greater than 500 copies/mL.
- ECOG performance status of 0 to 3.
- Adequate bone marrow function: Absolute neutrophil count (ANC) at least 1.5 x 10^9/L (at least 1.0 x 10^9/L if bone marrow involved); platelet count at least 80 x 10^9/L (at least 50 x 10^9/L if bone marrow involved); hemoglobin at least 80 g/L.
- Adequate organ function: Alanine aminotransferase (ALT) less than 3 times the upper limit of normal; total bilirubin less than 1.5 times upper limit of normal; serum creatinine less than 1.5 times upper limit of normal; NYHA heart function class 0-2; left ventricular ejection fraction (LVEF) above 50%.
You will not qualify if you...
- Aggressive NK-cell leukemia.
- Central nervous system lymphoma.
- History within 6 months of any of the following: acute myocardial infarction, unstable angina, congestive heart failure, uncontrolled symptomatic arrhythmia, complete left bundle branch block, second- or third-degree atrioventricular block, long QT syndrome or corrected QT interval (QTc) above 480 ms.
- Uncontrolled active infection.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 weeks depending on disease stage and treatment plan
Participants receive the P-P-GemOx immunochemotherapy regimen every 3 weeks. For those with stage I-II disease, treatment includes 2 cycles of immunochemotherapy, followed by radiotherapy, then 2 additional cycles. For stage III-IV disease, participants receive 6 cycles of immunochemotherapy. Response evaluations occur after 3 cycles and at completion of therapy.
Every 3 weeks corresponding to each treatment cycle
Duration - Up to 3 years
After treatment, participants are monitored for disease progression, survival, and adverse events for up to 3 years.
Regular follow-up visits scheduled over 3 years
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
W
Wei Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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