To hear about similar clinical trials, please enter your email below
Trial Title:
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
NCT ID:
NCT06583083
Condition:
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Gemcitabine
Oxaliplatin
Pegaspargase
Asparaginase
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab with P-GEMOX Regimen
Description:
Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine
intravenous drip, oxaliplatin intravenous drip
Arm group label:
experimental group
Other name:
Sintilimab, Pegaspargase, gemcitabine, oxaliplatin
Intervention type:
Drug
Intervention name:
P-GEMOX Regimen
Description:
Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin
intravenous drip
Arm group label:
control group
Other name:
Pegaspargase, gemcitabine, oxaliplatin
Summary:
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin
lymphoma. While the overall survival rates have improved for early-stage ENKTL patients,
the prognosis for those with advanced disease remains poor, and there is currently no
standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in
various cancers, and recent studies have shown promising results in extranodal NK/T-cell
lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or
refractory patients, their effectiveness when combined with chemotherapy as a first-line
treatment remains unclear. This study aims to evaluate the efficacy and safety of
sintilimab combined with chemotherapy in a randomized controlled trial for newly
diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential
biomarkers that may predict treatment outcomes, offering new therapeutic options for
extranodal NK/T-cell lymphoma patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically diagnosed with ENKTL.
2. Advanced stage.
3. Has at least one measurable or assessable lesion.
4. Age > 18 years, no gender restrictions, with an expected survival of more than 3
months.
5. Willing to participate in the clinical study; fully informed and has signed a
written informed consent form.
6. Adequate organ and bone marrow function.
Exclusion Criteria:
1. Aggressive NK-cell leukemia.
2. Central nervous system involvement.
3. Patients with significant dysfunction of vital organs.
4. History of allergy to the investigational drug, similar drugs, or excipients.
5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
6. Pregnant or breastfeeding women, and women of childbearing potential who are
unwilling to use contraception.
7. Active infection, excluding fever related to tumor-associated B symptoms.
8. Known history of human immunodeficiency virus (HIV) infection and/or acquired
immunodeficiency syndrome (AIDS).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Universitiy Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Cai Qingqing
Start date:
October 22, 2024
Completion date:
August 28, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06583083
