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

Primary Purpose

NK/T Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Dexamethasone, azacytidine, Pegaspargase, Tislelizumab

About this trial

This is an interventional treatment trial for NK/T Cell Lymphoma focused on measuring DAPT, Tislelizumab, Non- upper aerodigestive tract NK/T- cell lymphoma, R/R NK/T- cell lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
Peking University International Hospital
Peking University Cancer Hospital & Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate

To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma

Secondary Outcome Measures

Complete response rate

Progression-free survival

Overall survival

Adverse events

Full Information

NCT ID

NCT04899414

First Posted

May 19, 2021

Last Updated

May 19, 2021

Sponsor

Peking University

Collaborators

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT04899414

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 18, 2021 (Anticipated)

Primary Completion Date

May 18, 2023 (Anticipated)

Study Completion Date

October 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NK/T Cell Lymphoma

Keywords

DAPT, Tislelizumab, Non- upper aerodigestive tract NK/T- cell lymphoma, R/R NK/T- cell lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone, azacytidine, Pegaspargase, Tislelizumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall response rate

Description

To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma

Time Frame

1-year

Secondary Outcome Measure Information:

Title

Complete response rate

Time Frame

1-year

Title

Progression-free survival

Time Frame

2-year

Title

Overall survival

Time Frame

2-year

Title

Adverse events

Time Frame

1-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhu, Dr.

Phone

+86-13910333346

zhu-jun@bjcancer.org

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yexiong Li, Dr.

Facility Name

Peking University International Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaopei M Wang, Dr.

Facility Name

Peking University Cancer Hospital & Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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