Active — Not RecruitingPhase 2

Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

China34 participantsStarted 2019-10-09

Plain-language summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Who can participate

Age range18 Years – 75 Years

SexALL

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

Inclusion Criteria: * biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; * newly diagnosed stage III/IV patients; * at least one evaluable lesion； * ECOG PS 0-2; * 18-75 years; without other malignancy; * proper functioning of the major organs. Exclusion Criteria: * hemophagocytic syndrome or aggressive NK cell leukemia; * involvement of central nervous system; * previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

What they're measuring

complete remission (CR) rate

Timeframe: 2years

overall response rate (ORR)

Timeframe: 2years

Trial details

NCT IDNCT04127227

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-20

View on ClinicalTrials.gov More NK/T Cell Lymphoma Nos trials