NK/T Cell Lymphoma NosPhase 2NCT04231370
Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma
A Phase 2 study testing Sintilimab and Lenalidomide in people with NK/T Cell Lymphoma Nos, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NK/T Cell Lymphoma Nos
- What is being tested?
- Sintilimab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
- Blood routine: Hb>80g/L, PLT>50×10（9）/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- Sign the informed consent form.
- Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
Who cannot join
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
- Pregnant and lactating women.
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- Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
- Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, 100730
Liang Wang, MD, +8615001108693, wangliangtrhos@126.com
About this study
Official title: Combination of Lenalidomide and Sintilimab for Patients With Relapsed/Refractory NK/T-cell Lymphoma Who Failed Pegaspargase-based Regimens: a Single Arm, Open, Phase II Study
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.
Read the detailed description
Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.
- Conditions
- NK/T Cell Lymphoma Nos
- Being tested
- Sintilimab, Lenalidomide
- Keywords
- pegaspargase, sintilimab, PD-1, lenalidomide, relapsed/refractory
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called anti-PD-1-antibody
Sintilimab, 200mg, iv day1
LenalidomideDrug
Also called IMids
25mg/d oral d1-14
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks Receives: Drug: Sintilimab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete response
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Measured: 24 weeks ±7 days
Secondary outcomes (4)
Rate of overall response
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Measured: 24 weeks ±7 days
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Measured: up to 1year after enrollment
1-year overall survival rate
time from date of enrollment to date of death of any reason
Measured: up to 1year after enrollment
safety profiles
according to CTCAE 4.0
Measured: up to 1year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Apr 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Dec 2022 (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 Lymphoma NosStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Model description
- treatment with lenalidomide in combination with sintilimab for relapsed/refractory ENKTCL patients
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JING-WEN WANG, Beijing Tongren Hospital
- Investigators
- Jing-wen Wang, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231370
- Sponsor's protocol ID
- TRhos-ENKTCL-1
- Status last verified
- May 2020
- First submitted
- 14 Jan 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data in the trial can be shared upon request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Lenalidomide and Sintilimab for Patients With Relapsed/Refractory NK/T-cell Lymphoma Who Failed Pegaspargase-based Regimens: a Single Arm, Open, Phase II Study
- ClinicalTrials.gov ID
- NCT04231370
- Acronym / sponsor ID
- TRhos-ENKTCL-1
- Conditions
- NK/T Cell Lymphoma Nos
- Keywords
- pegaspargase, sintilimab, PD-1, lenalidomide, relapsed/refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jan 2020 (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 purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.
Detailed description
Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- treatment with lenalidomide in combination with sintilimab for relapsed/refractory ENKTCL patients
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Sintilimab, Drug: LenalidomideSintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
Key exclusion criteria (10 listed)
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 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 |
|---|---|---|
| SintilimabAlso: anti-PD-1-antibodySintilimab, 200mg, iv day1 | Drug | treatment arm |
| LenalidomideAlso: IMids25mg/d oral d1-14 | Drug | treatment arm |
Primary outcome
Rate of complete response
Time frame: 24 weeks ±7 days
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
4 secondary outcomes
Rate of overall response
Time frame: 24 weeks ±7 days
1-year progression free survival rate
Time frame: up to 1year after enrollment
1-year overall survival rate
Time frame: up to 1year after enrollment
safety profiles
Time frame: up to 1year after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No. All the data in the trial can be shared upon request to the PI.
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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.
Jing-wen Wang, M.D. principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab and Lenalidomide in people with NK/T Cell Lymphoma Nos, run by Beijing Tongren Hospital 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 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: status not confirmed, as of the sponsor's last update on 7 May 2020. 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.
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 LIANG WANG, M.D. (+8615013009093, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete response (time frame: 24 weeks ±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 7 May 2020.