A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma

ConditionNKTCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sintilimab
  • Pegaspargase
  • Selinexor
  • radiotherapy

Treatment groups

47 Participants
are divided into 1 treatment group

Sponsors and collaborators