Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL (SPENT)

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Treatments: Drug: Anti-PD-1 monoclonal antibody; Drug: Pegaspargase; Radiation: Definitive intensity-modulated radiotherapy (IMRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04676789

SYSUCC-ENKTL-002

Details and patient eligibility

About

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. After radiotherapy, patients with complete remission with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Full description

This is a multicentre, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be firstly treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles. If the patient achieves complete remission（CR）, standard radiotherapy will be performed, otherwise, they will receive concurrent chemoradiotherapy（CCRT）(radiation 50 Gy and two cycles of sintilimab and pegaspargase every 3 weeks). After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed ENKTL
• age:18-80years
• Ann Arbor stage IE,or stage IIE
• at lease one measurable lesion
• receive no chemotherapy or radiotherapy before
• Eastern CooperativeOncology Group performance status of 0 to 2.
• Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion criteria

• mismatch the inclusion criteria
• non-nasal type disease
• systematic central nervous system involvement
• previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention/treatment

Experimental group

Description:

Patients will receive sintilimab,200mg,ivdrip,day1; pegaspargase,2,500 unit/m2 deep intramuscular injection at three different sites,day 1, every 3 weeks for 4 cycles before radiation.Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent sintilimab of 200mg and pegaspargase,2,500 unit/m2 will be administered every 3 weeks for 2 cycles during IMRT for patients who do not achieve complete remission to previous induction therapy. After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Treatment:

Radiation: Definitive intensity-modulated radiotherapy (IMRT)

Drug: Pegaspargase

Drug: Anti-PD-1 monoclonal antibody