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Compares treatment options for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Official title Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
ClinicalTrials.gov ID: NCT06583083
What this study is testing
What is Sintilimab with P-GEMOX Regimen?
Sintilimab with P-GEMOX Regimen 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.
Also referred to as Sintilimab, Pegaspargase, gemcitabine, oxaliplatin.
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 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.
- 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 and older
You may be able to join if
- Pathologically diagnosed with ENKTL.
- Advanced stage.
- Has at least one measurable or assessable lesion.
- Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months.
- Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
You likely can't join if
- Aggressive NK-cell leukemia.
- Central nervous system involvement.
- Patients with significant dysfunction of vital organs.
- History of allergy to the investigational drug, similar drugs, or excipients.
- Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
See the full eligibility criteria
- Pathologically diagnosed with ENKTL.
- Advanced stage.
- Has at least one measurable or assessable lesion.
- Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months.
- Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
- Adequate organ and bone marrow function.
- Aggressive NK-cell leukemia.
- Central nervous system involvement.
- Patients with significant dysfunction of vital organs.
- History of allergy to the investigational drug, similar drugs, or excipients.
- Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- Active infection, excluding fever related to tumor-associated B symptoms.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.