A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: NK/T Cell Lymphoma Nos

Treatments: Drug: Pegaspargase; Drug: Oxaliplatin; Radiation: Definitive intensity-modulated radiotherapy (IMRT); Drug: Gemcitabine; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04365036

B2020-040-01

Details and patient eligibility

About

The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Enrollment: 207 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 I/II 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

toripalimab with P-GemOx

Experimental group

Description:

Patients will receive toripalimab and induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent toripalimab of 240mg will be administered every 3 weeks for 3 cycles during IMRT. Toripalimab 240mg will be given every 3 weeks for 13 cycles, started on day 1 of induction chemotherapy.

Treatment:

Drug: Toripalimab

Drug: Gemcitabine

Radiation: Definitive intensity-modulated radiotherapy (IMRT)

Drug: Oxaliplatin

Drug: Pegaspargase

P-GemOx

Active Comparator group

Description:

Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.

Treatment:

Drug: Gemcitabine

Radiation: Definitive intensity-modulated radiotherapy (IMRT)

Drug: Oxaliplatin

Drug: Pegaspargase