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

NCT ID: NCT04676789

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

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sintilimab Pegaspargase Definitive intensity-modulated radiotherapy (IMRT)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

treatment with sintilimab and pegaspargase combined with intensity-modulated radiotherapy (IMRT)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention/treatment

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.

Group Type EXPERIMENTAL

Pegaspargase

Intervention Type DRUG

Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1

Anti-PD-1 monoclonal antibody

Intervention Type DRUG

Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1

Definitive intensity-modulated radiotherapy (IMRT)

Intervention Type RADIATION

Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days

Interventions

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Pegaspargase

Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1

Intervention Type DRUG

Anti-PD-1 monoclonal antibody

Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1

Intervention Type DRUG

Definitive intensity-modulated radiotherapy (IMRT)

Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days

Intervention Type RADIATION

Other Intervention Names

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P-ASP sintilimab IMRT

Eligibility Criteria

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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)

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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wanghua

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hua Wang, MD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Please Select, China

Site Status

Countries

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China

Central Contacts

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Hua Wang, MD.

Role: CONTACT

Phone: 0086-20-87342462

Email: [email protected]

Other Identifiers

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SYSUCC-ENKTL-002

Identifier Type: -

Identifier Source: org_study_id