Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeNCT05058755
Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma
A study testing tislelizumab, azacytidine, lenalidomide and tislelizumab, etoposide, pegaspargase in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- tislelizumab, azacytidine, lenalidomide and tislelizumab, etoposide, pegaspargase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2021to 30 Dec 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.
- With progressive disease after asparaginase-based combined chemotherapy
- Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.
- PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.
- General ECOG score 0-3 points.
- The laboratory examination within 1 week before enrollment meets the following conditions:
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- Blood routine: Hb>80g/L, PLT>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more.
- Signed informed consent form.
- Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations.
Who cannot join
- Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).
- Severe infections require ICU treatment.
- Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.
- There are serious complications such as fulminant DIC.
- Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.
- Pregnant and lactating women.
- Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
Read the detailed description
About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.
- Being tested
- tislelizumab, azacytidine, lenalidomide, tislelizumab, etoposide, pegaspargase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab, azacytidine, lenalidomideDrug
Also called Tileilizhu Dankang
tislelizumab, 200mg, iv, day 1, every 21 days.
azacytidine, 75mg/m2, ih, days 1-7, every 21 days.
lenalidomide, 25mg, po, days 1-14, every 21 days.
tislelizumab, etoposide, pegaspargaseDrug
Also called Tileilizhu Dankang
tislelizumab, 200mg, iv, day 1, every 21 days.
etoposide, 100mg, iv, days 1-3, every 21 days.
pegaspargase, 2000U/m2, day 1, every 21 days
| Study group | Role | What they receive |
|---|---|---|
| TALE regimen | Experimental | tislelizumab plus azacytidine and lenalidomide Receives: Drug: tislelizumab, azacytidine, lenalidomide |
| TEPA regimen | Experimental | tislelizumab plus etoposide and pegaspargase Receives: Drug: tislelizumab, etoposide, pegaspargase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The overall response rate will be assessed on Week 12
Measured: Week 12 +/-7 days
Secondary outcomes (4)
Complete response rate
The complete response rate will be assessed on Week 12
Measured: Week 12 +/-7 days
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Measured: 1-year
Overall survival
Overall survival is defined as the time from entry onto the treatment until death of any reason
Measured: 1-year
Treatment-Related Adverse Events as Assessed by CTCAE v5.0
From day 1 of each course of chemotherapy to the 3 months after the last dose of therapy
Measured: Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start17 Sep 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Rong Tao, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058755
- Sponsor's protocol ID
- XHLSG-NK-1903
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05058755
- Acronym / sponsor ID
- XHLSG-NK-1903
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Sep 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.
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
Detailed description
About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TALE regimen | Experimental | Drug: tislelizumab, azacytidine, lenalidomidetislelizumab plus azacytidine and lenalidomide |
| TEPA regimen | Experimental | Drug: tislelizumab, etoposide, pegaspargasetislelizumab plus etoposide and pegaspargase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.
- With progressive disease after asparaginase-based combined chemotherapy
- Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.
- PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.
- General ECOG score 0-3 points.
Key exclusion criteria (7 listed)
- Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).
- Severe infections require ICU treatment.
- Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.
- There are serious complications such as fulminant DIC.
- Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.
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 |
|---|---|---|
| tislelizumab, azacytidine, lenalidomideAlso: Tileilizhu Dankangtislelizumab, 200mg, iv, day 1, every 21 days. azacytidine, 75mg/m2, ih, days 1-7, every 21 days. lenalidomide, 25mg, po, days 1-14, every 21 days. | Drug | TALE regimen |
| tislelizumab, etoposide, pegaspargaseAlso: Tileilizhu Dankangtislelizumab, 200mg, iv, day 1, every 21 days. etoposide, 100mg, iv, days 1-3, every 21 days. pegaspargase, 2000U/m2, day 1, every 21 days | Drug | TEPA regimen |
Primary outcome
Overall response rate
Time frame: Week 12 +/-7 days
The overall response rate will be assessed on Week 12
4 secondary outcomes
Complete response rate
Time frame: Week 12 +/-7 days
Progression free survival
Time frame: 1-year
Overall survival
Time frame: 1-year
Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- 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.
Rong Tao, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tislelizumab, azacytidine, lenalidomide and tislelizumab, etoposide, pegaspargase in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Week 12 +/-7 days). 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 4 Mar 2024.