Clinical trial NCT04899414: Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma
Official title: Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NK/T Cell Lymphoma
Keywords: DAPT
Tislelizumab
Non- upper aerodigestive tract NK/T- cell lymphoma
R/R NK/T- cell lymphoma
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2021-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate
timeFrame: 1-year
Secondary outcomes:
measure: Complete response rate
timeFrame: 1-year
measure: Progression-free survival
timeFrame: 2-year
measure: Overall survival
timeFrame: 2-year
measure: Adverse events
timeFrame: 1-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
References: