Status:
RECRUITING
"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL
Lead Sponsor:
Mingzhi Zhang
Conditions:
NKTCL
Selinexor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma
Detailed Description
Patients with early NK/T cell lymphoma were treated with an oral regimen of \"Selinisol + pemaspartase + dexamethasone\"
Eligibility Criteria
Inclusion
- 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 third-party consultation could be organized);
- 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 patients;
- 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 within 7 days before the first dose;
- The newly treated patient had not received other tumor-related treatment in the past;
- Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;
Exclusion
- 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 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related procedures within the last 6 months; Severe arrhythmias include frequent ventricular early, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure \>150mmHg, diastolic blood pressure \>100mmHg. Gastric ulcers (stomach ulcers that researchers have determined are at risk of perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren\'s syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory disease (such as obstructive pulmonary disease and a history of bronchospasm);
- 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 hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06559553
Start Date
September 1 2024
End Date
December 31 2026
Last Update
July 14 2025
Active Locations (1)
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1
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052