NKTCL
Conditions
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).
Interventions
DRUGSintilimab
Sintilimab will be given at 200 mg by intravenous infusion.
DRUGPegaspargase
Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
DRUGSelinexor
Selinexor will be given orally once weekly at 60mg.
RADIATIONradiotherapy
Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | Up to approximately 6 months | The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately 6 months | The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria. |
| Progression-Free Survival (PFS) | Up to 3 years | The time from enrollment to disease progression or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 3 years | The time from enrollment to death from any cause. |
| Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE) | Up to 30 days after the last study treatment | The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events. |
| Change in Quality of Life | Up to 3 years | Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire. |
Countries
China
Contacts
CONTACTQingqing Cai
Outcome results
None listed