Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma
Phase 2
- Conditions
- NK/T Cell Lymphoma
- Interventions
- Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab
- Registration Number
- NCT04899414
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma Dexamethasone, azacytidine, Pegaspargase, Tislelizumab 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
- Primary Outcome Measures
Name Time Method Overall response rate 1-year To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma
- Secondary Outcome Measures
Name Time Method Adverse events 1-year Complete response rate 1-year Progression-free survival 2-year Overall survival 2-year
Trial Locations
- Locations (3)
Peking University Cancer Hospital & Institute
🇨🇳Beijing, Beijing, China
National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China
Peking University International Hospital
🇨🇳Beijing, Beijing, China