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

May 19, 2021 updated by: Jun Zhu, Peking University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital & Institute
      • Beijing, Beijing, China, 100021
        • National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
          • Yexiong Li, Dr.
      • Beijing, Beijing, China, 100021
        • Peking University International Hospital
        • Contact:
          • Xiaopei M Wang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 18, 2021

Primary Completion (Anticipated)

May 18, 2023

Study Completion (Anticipated)

October 18, 2023

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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