NCT06583083

Brief Summary

Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
4mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
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 Progress83%
Oct 2024Aug 2026

First Submitted

Initial submission to the registry

August 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 22, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

August 28, 2024

Last Update Submit

April 9, 2026

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression free survival

    Up to 4 years

Secondary Outcomes (4)

  • ORR rate

    Up to 4 years

  • CR rate

    Up to 4 years

  • OS

    Up to 4 years

  • Adverse events

    Up to 4 years

Study Arms (2)

experimental group

EXPERIMENTAL

Sintilimab with P-GEMOX Regimen

Drug: Sintilimab with P-GEMOX Regimen

control group

ACTIVE COMPARATOR

P-GEMOX Regimen

Drug: P-GEMOX Regimen

Interventions

Sintilimab with P-GEMOX RegimenDRUG

Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Also known as: Sintilimab, Pegaspargase, gemcitabine, oxaliplatin
experimental group
P-GEMOX RegimenDRUG

Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Also known as: Pegaspargase, gemcitabine, oxaliplatin
control group

Eligibility Criteria

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

You may qualify if:

  • Pathologically diagnosed with ENKTL.
  • Advanced stage.
  • Has at least one measurable or assessable lesion.
  • Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months.
  • Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
  • Adequate organ and bone marrow function.

You may not qualify if:

  • Aggressive NK-cell leukemia.
  • Central nervous system involvement.
  • Patients with significant dysfunction of vital organs.
  • History of allergy to the investigational drug, similar drugs, or excipients.
  • Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
  • Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
  • Active infection, excluding fever related to tumor-associated B symptoms.
  • Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

sintilimabpegaspargaseGemcitabineOxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Central Study Contacts

Cai Qingqing, MD.PhD

CONTACT

(020)87342823caiqq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2024

First Posted

September 3, 2024

Study Start

October 22, 2024

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

CN(1)