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

NCT ID: NCT04899414

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2023-10-18

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.

Conditions

NK/T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dexamethasone, azacytidine, Pegaspargase, Tislelizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jun Zhu, Dr.

Role: CONTACT

zhu-jun@bjcancer.org

+86-13910333346

Facility Contacts

Yexiong Li, Dr.

Role: primary

Xiaopei M Wang, Dr.

Role: primary

Other Identifiers

DAPT for NKTCL

Identifier Type: -

Identifier Source: org_study_id