- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03363555
SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
June 17, 2020 updated by: Jiangsu HengRui Medicine Co., Ltd.
An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal 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 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored.
Study Type
Interventional
Enrollment (Anticipated)
97
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Henan
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Zhengzhou, Henan, China
- First Affiliated Hospital of Zhengzhou University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed extranodal NK/T cell lymphoma;
- Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
- Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- Need to provide ≥5 tumor tissue sections for detection.
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks.;
Adequate laboratory parameters during the screening period as evidenced by the following:
- Absolute neutrophil count ≥ 1.0× 109/L ;
- Platelets ≥ 75 × 109/L;
- Hemoglobin ≥ 8.0 g/dL;
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
- Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
- Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
- 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 60 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.
- Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
- invasive NK cell leukemia or precursor NK cell tumor
- Known central nervous system lymphoma
- Haemophilus cell syndrome at diagnosis
- Large lung vessels were involved
History and complication
- 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;
- Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted.
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10mg.
- Known and suspicion of interstitial pneumonia
- Other active malignancies that required treating.
- 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.
- 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.
laboratory test
- known HIV positive or known AIDS.
- Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
|
A humanized monoclonal immunoglobulin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from first patient first visit to 6 month after last patient first visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 29, 2018
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
December 5, 2017
First Posted (ACTUAL)
December 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 17, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1210-II-205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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