Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

NK/T Cell Lymphoma Nos Clinical Trial

Official title:

Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127227
• Other study ID #: B2019-148
• Status: Recruiting
• Phase: Phase 2
• Start date: October 9, 2019
• Est. completion date: October 9, 2023

Study information

• Verified date: September 2023
• Source: Sun Yat-sen University
• Contact: Qingqing Cai, MD
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: October 9, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
• newly diagnosed stage III/IV 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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• NK/T Cell Lymphoma Nos

Intervention

Drug:
• sintilimab,pegaspargase,gemcitabine,oxaliplatin
All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

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	complete remission (CR) rate		2years
Primary	overall response rate (ORR)		2years
Secondary	overall survival (OS)		2years
Secondary	progression survival (PFS)		2years
Secondary	disease-free survival (DFS)		2years
Secondary	bio-marker analysis	Correlation between programmed death-ligand 1 expression and efficacy	2years