Clinical trial NCT04676789: Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL
Official title: Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy As First-Line Treatment in Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: sintilimab
Pegaspargase
Definitive intensity-modulated radiotherapy (IMRT)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: treatment with sintilimab and pegaspargase combined with intensity-modulated radiotherapy (IMRT)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Secondary outcomes:
measure: complete remission (CR) rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: overall response rate (ORR)
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: overall survival (OS)
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: EBV-DNA load change
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Please Select
Study officials:
affiliation: Sun Yat-sen University
name: Hua Wang, MD.
role: PRINCIPAL_INVESTIGATOR
References: