Clinical trial · Interventional
Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma
Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma
NCT05058755CI-TRIAL-00074640completedN/AClinicalTrials.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)
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
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 |
|---|---|---|---|
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tislelizumab, azacytidine, lenalidomide | Drug | — | UNRESOLVED |
| tislelizumab, etoposide, pegaspargase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TALE regimen
- description
- tislelizumab plus azacytidine and lenalidomide
- interventionNames
- Drug: tislelizumab, azacytidine, lenalidomide
- type
- EXPERIMENTAL
- label
- TEPA regimen
- description
- tislelizumab plus etoposide and pegaspargase
- interventionNames
- Drug: tislelizumab, etoposide, pegaspargase
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Week 12 +/-7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma. 2. With progressive disease after asparaginase-based combined chemotherapy 3. Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease. 4. PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion. 5. General ECOG score 0-3 points. 6. The laboratory examination within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more. 7. Signed informed consent form. 8. Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations. Exclusion Criteria: 1. Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded). 2. Severe infections require ICU treatment. 3. Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded. 4. There are serious complications such as fulminant DIC. 5. Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months. 6. Pregnant and lactating women. 7. Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg.
References
Publications (0)
Data not yet available
No reference posted for this study.