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

Primary Purpose

NK/T Cell Lymphoma Nos

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sintilimab,pegaspargase,gemcitabine,oxaliplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NK/T Cell Lymphoma Nos

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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；

Sites / Locations

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sintilimab With P-GemOx

Arm Description

Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.

Outcomes

Primary Outcome Measures

complete remission (CR) rate
overall response rate (ORR)

Secondary Outcome Measures

overall survival (OS)
progression survival (PFS)
disease-free survival (DFS)
bio-marker analysis
Correlation between programmed death-ligand 1 expression and efficacy

Full Information

First Posted
October 10, 2019
Last Updated
September 25, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04127227
Brief Title
Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
October 9, 2023 (Anticipated)
Study Completion Date
October 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK/T Cell Lymphoma Nos

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab With P-GemOx
Arm Type
Experimental
Arm Description
Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.
Intervention Type
Drug
Intervention Name(s)
sintilimab,pegaspargase,gemcitabine,oxaliplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
complete remission (CR) rate
Time Frame
2years
Title
overall response rate (ORR)
Time Frame
2years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
2years
Title
progression survival (PFS)
Time Frame
2years
Title
disease-free survival (DFS)
Time Frame
2years
Title
bio-marker analysis
Description
Correlation between programmed death-ligand 1 expression and efficacy
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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；
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Ma, MD

12. IPD Sharing Statement

Learn more about this trial

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

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