NK/T Cell LymphomaPhase 2NCT04899414
Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma
A Phase 2 study testing Dexamethasone, azacytidine, Pegaspargase, Tislelizumab in people with NK/T Cell Lymphoma, run by Peking University at 3 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NK/T Cell Lymphoma
- What is being tested?
- Dexamethasone, azacytidine, Pegaspargase, Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 18 May 2021to 18 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yexiong Li, Dr.
Peking University International Hospital
Beijing, Beijing Municipality, 100021
Xiaopei M Wang, Dr.
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
About this study
Official title: 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.
- Conditions
- NK/T Cell Lymphoma
- Being tested
- Dexamethasone, azacytidine, Pegaspargase, Tislelizumab
- Keywords
- DAPT, Tislelizumab, Non- upper aerodigestive tract NK/T- cell lymphoma, R/R 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.
Dexamethasone, azacytidine, Pegaspargase, TislelizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma | Experimental | 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 Receives: Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma
Measured: 1-year
Secondary outcomes (4)
Complete response rate
Measured: 1-year
Progression-free survival
Measured: 2-year
Overall survival
Measured: 2-year
Adverse events
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start18 May 2021 (estimated)
- Primary completion18 May 2023 (estimated)
- Study completion18 Oct 2023 (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 UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Jun Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899414
- Sponsor's protocol ID
- DAPT for NKTCL
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04899414
- Acronym / sponsor ID
- DAPT for NKTCL
- Conditions
- NK/T Cell Lymphoma
- Keywords
- DAPT, Tislelizumab, Non- upper aerodigestive tract NK/T- cell lymphoma, R/R NK/T- cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 18 May 2021 (estimated)
- Primary completion
- 18 May 2023 (estimated)
- Study completion
- 18 Oct 2023 (estimated)
- First posted
- 24 May 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma | Experimental | Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab4-6 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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);
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 |
|---|---|---|
| Dexamethasone, azacytidine, Pegaspargase, TislelizumabDexamethasone 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. | Drug | Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma |
Primary outcome
Overall response rate
Time frame: 1-year
To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma
4 secondary outcomes
Complete response rate
Time frame: 1-year
Progression-free survival
Time frame: 2-year
Overall survival
Time frame: 2-year
Adverse events
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Dexamethasone, azacytidine, Pegaspargase, Tislelizumab in people with NK/T Cell Lymphoma, run by Peking University 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 13 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhu, Dr. (+86-13910333346, zhu-jun@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 1-year). 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 24 May 2021.