RecruitingPhase 1/2

"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL

China50 participantsStarted 2024-09-01

Plain-language summary

evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;

CRR

Timeframe: From date of randomization until the date tumor volume has reduced, assessed up to 36 months

NCT IDNCT06559553

SponsorMingzhi Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Zhang Mingzhi Mingzhi Zhang, PhD

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;