Combination treatment for early stage NK/T-cell lymphoma

A Prospective Clinical Study of "Selinexor+Pegaspargase+Dexamethasone" in the Treatment of Stage Ⅰ/Ⅱ NK/ T-Cell Lymphoma

This study is testing a new combination treatment for early-stage NK/T-cell lymphoma to see if it helps patients feel better and is safe to use.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhengzhou University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06559553 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination treatment involving Selinexor, Pegaspargase, and Dexamethasone in patients with early-stage NK/T-cell lymphoma. Participants aged 18 to 70 with confirmed NK/T-cell lymphoma will receive this oral regimen to assess its effectiveness in managing their condition. The study aims to determine how well this treatment works and its safety profile in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with confirmed early-stage NK/T-cell lymphoma and acceptable hematological and liver function.

Not a fit: Patients with advanced-stage NK/T-cell lymphoma or those with significant contraindications to chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with early-stage NK/T-cell lymphoma.

How similar studies have performed: While there have been studies on individual components of this treatment, the specific combination approach in this trial is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
2. Pre-survival time \> 6 months;
3. 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);
4. Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
5. 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);
6. 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;
7. Renal function: serum creatinine ≤1.5×ULN;
8. 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;
9. The newly treated patient had not received other tumor-related treatment in the past;
10. Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;

Exclusion Criteria:

1. Refuse to collect blood samples;
2. Previous allergy to any of the drugs in the program;
3. Pregnant and lactating women;
4. Major diseases that the investigator believes can cause interference with the test;
5. Combined with other tumors;
6. There are contraindications related to therapeutic drugs in the program;
7. Persons with serious mental illness;
8. Participating in other clinical trials;
9. Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
10. 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);
11. Hemophagic cell syndrome;
12. Researchers do not consider it suitable for inclusion;
13. 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.

Where this trial is running

Zhengzhou, Henan

• Oncology Department of The First Affilliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Zhang Mingzhi Mingzhi Zhang, PhD

Conditions NKTCL; Selinexor