Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma

Study Overview
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Brief Summary
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The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of Dexamethasone, azacytidine, Pegaspargase, Tislelizumab (DAPT) regimen for patients with newly diagnosed advanced stage ENKTL , non-upper aerodigestive tract NK/T- cell lymphoma（NUAT- NKTCL）and relapsed refractory NK/T cell lymphoma.

Official Title
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Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma

Conditions
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NK/T Cell Lymphoma

Intervention / Treatment
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* Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-70 years ,Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria at least one measurable lesion hemoglobin ≥90 g/l, absolute neutrophil count ≥ 1.5 × 10^9/L, platelets ≥ 75 ×10^9/L), ALT≤ 2 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal （If the above indicators are abnormal but are caused by the primary disease as assessed by the clinician, the treatment can be enrolled according to the clinical actual situation） There was no other serious disease in conflict with this program Adequate respiratory function Adequate bone marrow function Adequate renal and hepatic function Not pregnant or nursing ,negative pregnancy test No other active malignancy requiring therapy No other serious or life-threatening condition deemed unacceptable by the principal investigator Life expectancy ≥ 3 months Able to understand and sign an informed consent form (ICF). Exclusion Criteria: NK/T cell lymphoma without confirmed pathological diagnosis; Patients with early stage upper aerodigestive tract NK/T- cell lymphoma ; Patients with drug allergies or metabolic disorders in the program; Any uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction); Severe infection (excluding the following: HBsAg or anti-HBc positive patients taking entecavir, tenofovir and other drugs;HCV RNA positive but taking direct anti-HCV drugs); Invasion of primary or secondary central nervous system tumor invasion; Contradictions to chemotherapy or radiotherapy; Previously other malignancy requiring therapy; Peripheral nervous system disorder or mental disorder; Incapacity for legal conduct, medical or ethical reasons that affect the continuation of the research; Other clinical investigators; Combination of anti-tumor drugs outside the research program; Participants evaluated inappropriate to participate in this study by principal investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma<br>4-6 cycles of induction DAPT followed by Auto HSCT as consolidation for CR/PR fit patients ,then by PD-1 as maintenance treatment (up to 16 cycles) for received Auto-HSCT | Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab<br>* Dexamethasone 40mg intravenously daily on day 1-4; azacytidine 100mg intravenously daily on day 1-5; Pegaspargase 3750 IU intravenously daily on day 1； Tislelizumab 200 mg IV on Day 1 of each 21-day as a cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 1-year | 
| Progression-free survival |  | 2-year | 
| Overall survival |  | 2-year | 
| Adverse events |  | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAPT, Tislelizumab, Non- upper aerodigestive tract NK/T- cell lymphoma, R/R NK/T- cell lymphoma