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

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

— SPENT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04676789
• Other study ID #: SYSUCC-ENKTL-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2020
• Source: Sun Yat-sen University
• Contact: Hua Wang, MD.
• Phone: 0086-20-87342462
• Email: wanghua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Pegaspargase
Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1
• Anti-PD-1 monoclonal antibody
Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)	Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy, or death from any cause, whichever occurred first.	Baseline up to data cut-off (up to approximately 4 years)
Secondary	complete remission (CR) rate	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.	At the end of Cycle 6 (each cycle is 21 days)
Secondary	overall response rate (ORR)	Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.	At the end of Cycle 6 (each cycle is 21 days)
Secondary	overall survival (OS)	Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.	Baseline up to data cut-off (up to approximately 4 years)
Secondary	Duration of response	Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.	Baseline up to data cut-off (up to approximately 4 years)
Secondary	EBV-DNA load change	EBV-DNA load at each cycle for comparison	At the end of Cycle 6 (each cycle is 21 days)
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	Baseline up to data cut-off (up to approximately 4 years)