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

Sponsor
Sun Yat-sen University
Study ID
NCT07574528
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NKTCL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab will be given at 200 mg by intravenous infusion.
  • Pegaspargase — DRUG
    Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
  • Selinexor — DRUG
    Selinexor will be given orally once weekly at 60mg.
  • radiotherapy — RADIATION
    Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.

Study Details

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).

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Mar 6, 2028
Completion
May 6, 2031

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Up to approximately 6 months ]

Central Contacts