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

NCT07000617 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-1-2151
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

NK/T Cell Lymphoma

Keywords

NK/T cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

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

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (4)

• Objective response rate

  From enrollment to the end of treatment at 8 weeks

• 2-year progression-free survival rate

  From enrollment to 2 years after the end of treatment

• 2-year overall survival rate

  From enrollment to 2 years after the end of treatment

• Adverse events

  From enrollment to the end of treatment at 1 month

Other Outcomes (1)

• Exploratory biomarker analyses

  From enrollment to 2 years after the end of treatment

Study Arms (1)

DAPT regimen plus radiotherapy

EXPERIMENTAL

Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen consists of dexamethasone, azacitidine, pegaspargase and tislelizumab.

Drug: DAPT regimen plus radiotherapy

Interventions

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.

DAPT regimen plus radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Peking University International Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (3)

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

Beijing, China

RECRUITING

Peking University Cancer Hospital

Beijing, China

RECRUITING

Peking University International Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yuqin Song

CONTACT

+86-10-88196116; songyuqin622@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (3)