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

Overview

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.

Full Title of Study: “Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 18, 2023

Interventions

  • Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab
    • 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.

Arms, Groups and Cohorts

  • Experimental: Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate
    • Time Frame: 1-year
    • To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma

Secondary Measures

  • Complete response rate
    • Time Frame: 1-year
  • Progression-free survival
    • Time Frame: 2-year
  • Overall survival
    • Time Frame: 2-year
  • Adverse events
    • Time Frame: 1-year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University
  • Collaborator
    • Beijing Cancer Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Zhu, Dr. – Beijing Cancer Hospital
  • Overall Contact(s)
    • Jun Zhu, Dr., +86-13910333346, zhu-jun@bjcancer.org

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