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New treatment option for NKTCL
Official title "Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL
ClinicalTrials.gov ID: NCT06559553
What this study is testing
What is Selinexor+pegaspargase+dexamethasone?
Selinexor+pegaspargase+dexamethasone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nktcl.
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
- evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma
- Phase 2: a mid-size study of how well it works
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 70
You may be able to join if
- Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
- Pre-survival time \> 6 months;
- The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted)...
- Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
- Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10\^9 /L, platelet ≥75×10\^9 /L, hemoglobin...
You likely can't join if
- Refuse to collect blood samples;
- Previous allergy to any of the drugs in the program;
- Pregnant and lactating women;
- Major diseases that the investigator believes can cause interference with the test;
- Combined with other tumors;
- There are contraindications related to therapeutic drugs in the program;
See the full eligibility criteria
- Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
- Pre-survival time \> 6 months;
- The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic...
- Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
- Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10\^9 /L, platelet ≥75×10\^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
- Liver function: direct bilirubin ≤1.5× upper limit reference value; Glutamic pyruvic transaminase or glutamic oxalacetic transaminase ≤2.5× upper limit reference value; Alkaline phosphatase ≤3×ULN in non-bone invaded...
- Renal function: serum creatinine ≤1.5×ULN;
- Female and male patients of reproductive age and their spouses are willing to use adequate contraception throughout the study period, and female patients of reproductive age must have a negative serum pregnancy test...
- The newly treated patient had not received other tumor-related treatment in the past;
- people voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;
- Refuse to collect blood samples;
- Previous allergy to any of the drugs in the program;
- Pregnant and lactating women;
- Major diseases that the investigator believes can cause interference with the test;
- Combined with other tumors;
- There are contraindications related to therapeutic drugs in the program;
- Persons with serious mental illness;
- Participating in other clinical trials;
- Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
- Other serious medical conditions that may limit participants\' participation in the trial, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome within the last 6...
- Hemophagic cell syndrome;
- Researchers do not consider it suitable for inclusion;
- Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, 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.