NCT04127227

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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
17mo left

Started Oct 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2019Oct 2027

Study Start

First participant enrolled

October 9, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2027

Expected
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

October 10, 2019

Last Update Submit

February 28, 2026

Conditions

NK/T Cell Lymphoma Nos

Outcome Measures

Primary Outcomes (2)

  • complete remission (CR) rate

    2years

  • overall response rate (ORR)

    2years

Secondary Outcomes (4)

  • overall survival (OS)

    2years

  • progression survival (PFS)

    2years

  • disease-free survival (DFS)

    2years

  • bio-marker analysis

    2years

Study Arms (1)

Sintilimab With P-GemOx

EXPERIMENTAL

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.

Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin

Interventions

sintilimab,pegaspargase,gemcitabine,oxaliplatinDRUG

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

Sintilimab With P-GemOx

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years; without other malignancy;
  • proper functioning of the major organs.

You may not qualify if:

  • hemophagocytic syndrome or aggressive NK cell leukemia;
  • involvement of central nervous system;
  • previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 51000, China

Location

Related Publications (1)

  • Tian XP, Cai J, Xia Y, Zhang YC, Wang L, Liu PP, Huang HQ, Li YJ, Zhou H, Li ZM, Yang J, Wei LQ, Zou QH, Huang Y, Li J, Ling L, Zhong WL, Cai QQ. First-line sintilimab with pegaspargase, gemcitabine, and oxaliplatin in advanced extranodal natural killer/T cell lymphoma (SPIRIT): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 May;11(5):e336-e344. doi: 10.1016/S2352-3026(24)00066-8. Epub 2024 Mar 27.

    PMID: 38554717DERIVED

MeSH Terms

Interventions

sintilimab

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 15, 2019

Study Start

October 9, 2019

Primary Completion

July 20, 2023

Study Completion (Estimated)

October 9, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

CN(1)