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NCT Number: NCT07000617

A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma

The goal of this clinical trial is to learn if the regimen of dexamethasone, azacitidine, pegaspargase and tislelizumab (DAPT regimen) combined with radiotherapy works to treat stage I or II NK/T cell lymphoma in adults. It will also learn about the safety of the DAPT regimen. The main questions it aims to answer are:

What are the efficacy of the DAPT regimen plus radiotherapy in participants with extranodal NK/T-cell lymphoma? What medical problems do participants have when taking the DAPT regimen?

Participants will:

Receive the DAPT regimen every 21 days for 6 cycles and radiotherapy Visit the clinic according to clinical trial requirement for checkups and tests Receive blood tests and radiological imaging tests according to the clinical trial requirement

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Key information

Conditions

NK/T Cell Lymphoma Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
  • Age ≥18 years
  • Ann Arbor stage I or II
  • Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
  • ECOG-PS 0~2
  • Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
  • Expected survival of at least 3 months
  • Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.

Exclusion criteria

  • Unconfirmed pathological diagnosis of NK/T-cell lymphoma
  • Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
  • Patients with clinically significant prolonged QTc interval (>470ms in males, >480ms in females), ventricular tachycardia, atrial fibrillation, second or third degree atrioventricular block, acute myocardial infarction, congestive heart failure, severe or symptomatic coronary artery disease requiring medical treatment.
  • Patients with large amount of pericardial effusions shown by echocardiogram.
  • Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
  • Patients with severe active bleeding.
  • Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
  • Patients with active infectious disease.
  • Patients who are mentally disabled or unable to understand or sign the informed consent form.
  • Patients with other conditions judged as ineligible for this study by the investigators.

Treatment and study plan

DAPT regimen plus radiotherapy

Drug

Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen is administered as follows: dexamethasone 10mg intravenously on days1-3, azacitidine 100mg subcutaneously on days 1-5, pegaspargase 2500IU/m2 intramuscularly on day 1, and tislelizumab 200mg intravenously on day 6, repeated every 21 days. Concurrent radiotherapy given to the tumor sites is started after 2 cycles of DAPT regimen. The specific doses and methods of radiotherapy are in accordance with the clinical guidelines for NK/T-cell lymphoma.

Primary outcomes

  1. Complete response rate

    Time frame: From enrollment to the end of treatment at 8 weeks

    Complete response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma.

Secondary outcomes

  1. Objective response rate

    Time frame: From enrollment to the end of treatment at 8 weeks

    Objective response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma, including complete response and partial response.

  2. 2-year progression-free survival rate

    Time frame: From enrollment to 2 years after the end of treatment

    Progression-free survival (PFS) is measured from the time of start of treatment to the time of first progression, relapse after response, death from any cause, or the date of last follow-up. 2-year PFS rate will be estimated using the Kaplan-Meier method.

  3. 2-year overall survival rate

    Time frame: From enrollment to 2 years after the end of treatment

    Overall survival (OS) is defined as the time from the start of treatment to the time of death from any cause or the date of last follow-up. The 2-year OS rate will be estimated using the Kaplan-Meier method.

  4. Adverse events

    Time frame: From enrollment to the end of treatment at 1 month

    All adverse events will be recorded and graded according to CTCAE 5.0

Other outcomes

  1. Exploratory biomarker analyses

    Time frame: From enrollment to 2 years after the end of treatment

    Patients' tumor tissue and blood samples will be collected and analyzed to explore predictive biomarkers for treatment response and prognosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuqin Song

CONTACT

[email protected]

+86-10-88196116

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Chinese Academy of Medical Sciences
  • Peking University International Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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