NCT07574528

Brief Summary

This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).

Trial Health

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Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
61mo left

Started May 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2028

Expected
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2031

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

NKTCL

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate (CRR)

    The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.

    Up to approximately 6 months

Secondary Outcomes (5)

  • Overall Response Rate (ORR)

    Up to approximately 6 months

  • Progression-Free Survival (PFS)

    Up to 3 years

  • Overall Survival (OS)

    Up to 3 years

  • Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)

    Up to 30 days after the last study treatment

  • Change in Quality of Life

    Up to 3 years

Study Arms (1)

Sintilimab, pegaspargase, and selinexor

EXPERIMENTAL

Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy.

Drug: SintilimabDrug: PegaspargaseDrug: SelinexorRadiation: radiotherapy

Interventions

SintilimabDRUG

Sintilimab will be given at 200 mg by intravenous infusion.

Sintilimab, pegaspargase, and selinexor
PegaspargaseDRUG

Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.

Sintilimab, pegaspargase, and selinexor
SelinexorDRUG

Selinexor will be given orally once weekly at 60mg.

Sintilimab, pegaspargase, and selinexor
radiotherapyRADIATION

Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.

Sintilimab, pegaspargase, and selinexor

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older.
  • No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
  • Life expectancy of more than 3 months.
  • Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Histologically confirmed extranodal natural killer/T-cell lymphoma.
  • Primary lesion located in the nasal cavity or upper aerodigestive tract.
  • Stage I to II disease.
  • At least one measurable or evaluable lesion according to Lugano 2014 criteria.
  • Adequate organ and bone marrow function.

You may not qualify if:

  • Aggressive NK-cell leukemia.
  • Significant dysfunction of major organs.
  • Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
  • Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
  • Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, 广东省 - Guangdong Sheng, 510060, China

Location

MeSH Terms

Interventions

sintilimabpegaspargaseselinexorRadiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Qingqing Cai

CONTACT

+8618353201165caiqq@sysucc.org.cn

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
Professor and Chief Physician

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

March 6, 2028

Study Completion (Estimated)

May 6, 2031

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)