NK/T-cell LymphomaPhase 2NCT03701022
PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma
A Phase 2 study testing SHR1210 in people with NK/T-cell Lymphoma, run by Peking University.
Trial summary
This is an open-label, single-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 combined with Apatinib in subjects with relapsed or refractory NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NK/T-cell Lymphoma
- What is being tested?
- SHR1210
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 30 Jun 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed extranodal NK/T cell lymphoma nasal, PTCL,NOS, AITL, ALCL;
- Subjects must be recurrent or refractory, and 10-15 white tumors of tumor tissue should be provided.
- Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- ECOG performance status of 0 or 1;
- 6.Life expectancy ≥ 12 weeks.; 7.Adequate laboratory parameters during the screening period as evidenced by the following:
- a.Absolute neutrophil count ≥ 1.5× 109/L ; b.Platelets ≥ 100 × 109/L; c.Hemoglobin ≥ 9.0 g/dL; d.Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN e.Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min; f.Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN 8.Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
- 9.Able to understand and sign an informed consent form (ICF).
Who cannot join
- Known central nervous system lymphoma
- Haemophilus cell syndrome at diagnosis
- Large lung vessels were involved
- History and complication
- Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
- Subjects requiring systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents were given the study drug within 14 days prior to administration. Inhaled or topical corticosteroids and adrenaline replacement at a therapeutic dose of more than 10 mg/day prednisone are allowed in the absence of active autoimmune disease
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- Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
- Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
- Known and suspicion of interstitial pneumonia
- History of other malignancies except in patients with basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, or carcinoma of the cervix in situ who had undergone potential curable treatment and had no recurrence within five years of initiation of self-treatment;
- Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
- Prior allo-HSCT.
- ASCT within 90 days.
- Impact of major surgery or severe trauma had been eliminated for less than 14 days.
- Active pulmonary tuberculosis.
- Severe acute or chronic infection requiring systemic therapy.
- In the first 2 months before treatment, there was a significant amount of half a teaspoon (2.5ml) of blood or hemoptysis
- Significant clinical symptoms of bleeding or a clear tendency to bleed occurred within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc;
- Arteriovenous thrombotic events, such as cerebral vascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first six months of treatment.
- Known hereditary or acquired bleeding and thrombotic tendencies ;
- Suffering from hypertension, and the treatment of hypotensive drugs can not get good control.(systolic blood pressure is greater than 140 mmHg or diastolic pressure is more than 90 mmHg);
- Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months;
- Live vaccinations were given within four weeks before the study drug was administered. Inactivated viral vaccines for seasonal influenza were allowed, but live attenuated influenza vaccines for intranasal use were not allowed.
- laboratory test
- known HIV positive or known AIDS.
- Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2G / L) having tends to bleed or is undergoing thrombolytic or anticoagulant therapy;
- Routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1 g.
- Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
- Women suffering from pregnancy or lactation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-lable, Single Arm, Single Center, Phase 2 Study of PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell
This is an open-label, single-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 combined with Apatinib in subjects with relapsed or refractory NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Read the detailed description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 combined with Apatinib in patients with relapsed or refractory NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years，safety and immunogenicity of SHR-1210 combined with Apatinib in relapsed or refractory NK/T cell lymphoma.
- Conditions
- NK/T-cell Lymphoma
- Being tested
- SHR1210
- 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.
SHR1210Drug
Also called Apatinib
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day.
| Study group | Role | What they receive |
|---|---|---|
| SHR1210 +Apatinib | Experimental | SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Receives: Drug: SHR1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
rate of subjects achieved complete response plus partial response in all evaluable subjects
Measured: from first patient first visit to 6 month after last patient first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Jun 2021 (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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Yuqin Song, Principal investigator, Cancer Hospital of Beijing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701022
- Sponsor's protocol ID
- SHR-1210-APTN-IIT-NKT lymphoma
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 9 Oct 2018
- 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-lable, Single Arm, Single Center, Phase 2 Study of PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell
- ClinicalTrials.gov ID
- NCT03701022
- Acronym / sponsor ID
- SHR-1210-APTN-IIT-NKT lymphoma
- Conditions
- NK/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 9 Oct 2018 (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.
This is an open-label, single-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 combined with Apatinib in subjects with relapsed or refractory NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Detailed description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 combined with Apatinib in patients with relapsed or refractory NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years，safety and immunogenicity of SHR-1210 combined with Apatinib in relapsed or 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 |
|---|---|---|
| SHR1210 +Apatinib | Experimental | Drug: SHR1210SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed extranodal NK/T cell lymphoma nasal, PTCL,NOS, AITL, ALCL;
- Subjects must be recurrent or refractory, and 10-15 white tumors of tumor tissue should be provided.
- Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- ECOG performance status of 0 or 1;
- 6.Life expectancy ≥ 12 weeks.; 7.Adequate laboratory parameters during the screening period as evidenced by the following:
Key exclusion criteria (31 listed)
- Known central nervous system lymphoma
- Haemophilus cell syndrome at diagnosis
- Large lung vessels were involved
- History and complication
- laboratory test
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 |
|---|---|---|
| SHR1210Also: ApatinibSHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day. | Drug | SHR1210 +Apatinib |
Primary outcome
objective response rate
Time frame: from first patient first visit to 6 month after last patient first visit
rate of subjects achieved complete response plus partial response in all evaluable subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- 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.
Yuqin Song principal investigator
Cancer Hospital of Beijing University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR1210 in people with NK/T-cell Lymphoma, run by Peking University.
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 7 inclusion and 31 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Yuqin Song (+13683398726, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: from first patient first visit to 6 month after last patient first visit). 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 9 Oct 2018.