Clinical trial · Interventional
A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
NCT07574528CI-TRIAL-00110862not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NKTCL | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegaspargase | Drug | Pegaspargase | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Selinexor | Drug | Selinexor | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab, pegaspargase, and selinexor
- description
- Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy.
- interventionNames
- Drug: Sintilimab
- Drug: Pegaspargase
- Drug: Selinexor
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Complete Response Rate (CRR)
- timeFrame
- Up to approximately 6 months
- description
- The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.
Secondary outcomes (5)
- measure
- Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.