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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: NK/T Cell Lymphoma Nos

Treatments: Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04127227

B2019-148

Details and patient eligibility

About

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)

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Sintilimab With P-GemOx

Experimental group

Description:

Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.

Treatment:

Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin