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

Last updated: May 24, 2025
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Non-hodgkin's Lymphoma

Lymphoma

Treatment

DAPT regimen plus radiotherapy

Clinical Study ID

NCT07000617
2024-1-2151
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma

  2. Age ≥18 years

  3. Ann Arbor stage I or II

  4. Presence of at least 1 measurable lesion according to the 2014 Lugano revisedcriteria for response assessment

  5. ECOG-PS 0~2

  6. Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/Land hemoglobin ≥90g/L

  7. Expected survival of at least 3 months

  8. Capable of understanding the content of this study, agreeing to participate in thisstudy and signing the informed consent.

Exclusion

Exclusion Criteria:

  1. Unconfirmed pathological diagnosis of NK/T-cell lymphoma

  2. Pregnant or lactating women, or patients of childbearing age unwilling to takecontraceptive measures during the study period.

  3. Patients with clinically significant prolonged QTc interval (>470ms in males, >480msin females), ventricular tachycardia, atrial fibrillation, second or third degreeatrioventricular block, acute myocardial infarction, congestive heart failure,severe or symptomatic coronary artery disease requiring medical treatment.

  4. Patients with large amount of pericardial effusions shown by echocardiogram.

  5. Patients who received supportive care for anemia, neutropenia or thrombocytopeniawithin 7 days prior to start of study treatment.

  6. Patients with severe active bleeding.

  7. Patients with pulmonary embolism, intracranial hemorrhage or acute cerebralinfarction.

  8. Patients with active infectious disease.

  9. Patients who are mentally disabled or unable to understand or sign the informedconsent form.

  10. Patients with other conditions judged as ineligible for this study by theinvestigators.

Study Design

Total Participants: 57
Treatment Group(s): 1
Primary Treatment: DAPT regimen plus radiotherapy
Phase: 2
Study Start date:
March 21, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

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

    Beijing,
    China

    Active - Recruiting

  • Peking University Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University International Hospital

    Beijing,
    China

    Active - Recruiting

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