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

NK/T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04899414
• Other study ID #: DAPT for NKTCL
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 18, 2021
• Est. completion date: October 18, 2023

Study information

• Verified date: May 2021
• Source: Peking University
• Contact: Jun Zhu, Dr.
• Phone: +86-13910333346
• Email: zhu-jun[@]bjcancer.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• NK/T Cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Peking University Cancer Hospital & Institute	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma	1-year
Secondary	Complete response rate		1-year
Secondary	Progression-free survival		2-year
Secondary	Overall survival		2-year
Secondary	Adverse events		1-year