NK/T Cell LymphomaPhase 2NCT07000617
A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
A Phase 2 study testing DAPT regimen plus radiotherapy in people with NK/T Cell Lymphoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NK/T Cell Lymphoma
- What is being tested?
- DAPT regimen plus radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesChina
- Study dates
- 21 Mar 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Shunan Qi, +86-10-67781331, medata@163.com
- Recruiting
Peking University Cancer Hospital
Beijing
Shaoxuan Hu, +86-10-88196116, hsxhy123654@sina.com
- Recruiting
Peking University International Hospital
Beijing
Linjun Zhao, +86-10-69006840, zhaolinjun@pkuih.edu.cn
About this study
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?
Read more
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
- Being tested
- DAPT regimen plus radiotherapy
- Keywords
- NK/T cell lymphoma
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPT regimen plus radiotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DAPT regimen plus radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (4)
Objective response rate
Objective response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma, including complete response and partial response.
Measured: From enrollment to the end of treatment at 8 weeks
2-year progression-free survival rate
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.
Measured: From enrollment to 2 years after the end of treatment
2-year overall survival rate
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.
Measured: From enrollment to 2 years after the end of treatment
Adverse events
All adverse events will be recorded and graded according to CTCAE 5.0
Measured: From enrollment to the end of treatment at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start21 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK/T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000617
- Sponsor's protocol ID
- 2024-1-2151
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07000617
- Acronym / sponsor ID
- 2024-1-2151
- Conditions
- NK/T Cell Lymphoma
- Keywords
- NK/T cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Chinese Academy of Medical Sciences
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAPT regimen plus radiotherapy | Experimental | Drug: DAPT regimen plus radiotherapyPatients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen consists of dexamethasone, azacitidine, pegaspargase and tislelizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPT regimen plus radiotherapyPatients 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. | Drug | DAPT regimen plus radiotherapy |
Primary outcome
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.
4 secondary outcomes
Objective response rate
Time frame: From enrollment to the end of treatment at 8 weeks
2-year progression-free survival rate
Time frame: From enrollment to 2 years after the end of treatment
2-year overall survival rate
Time frame: From enrollment to 2 years after the end of treatment
Adverse events
Time frame: From enrollment to the end of treatment at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAPT regimen plus radiotherapy in people with NK/T Cell Lymphoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song (+86-10-88196116, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.