Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial.
- Conditions
- Peripheral T cell lymphoma
- Registration Number
- JPRN-UMIN000034499
- Lead Sponsor
- Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
1)CNS lymphoma, intracerebral or BM infiltration 2)Autoimmune disease or history of chronic or recurrent autoimmune disease 3)History of interstitial lung disease or pulmonary fibrosis 4)Diverticulitis or symptomatic gastrointestinal ulcer 5)Auto-HSCT within 90days before the administration start 6)Anticancer therapy within 28days before the administration start 7)Mogamulizumab within 28days before the administration start 8)Other investigational new drugs within 28days or within less than 5times of elimination half-time before the administration start 9)Radiotherapy within 28days before the administration start 10)Systemic adrenal cortical hormone more than 10mg/day by prednisolone conversion or immunosuppressant within 28days before the administration start 11)All other investigational new drugs within 28days before the administration start(antibody preparation: within 90days) 12)Local or surface anesthesia, or operative treatment associated with general anesthesia within 14days before the administration start 13)Active double cancer. 14)Anamnesis of transient cerebral ischemic attack, cerebrovascular attack, thrombosis or the thromboembolism within 180days before enrollment 15)Remained influence of side effect of pre-treatment or operative treatmen 16)Following uncontrollable or severe cardiovascular diseases within 180days before enrollment a)Myocardial infarction b)Uncontrollable angina pectoris c)Congestive heart failure of NYHA classification grade III or IV d)Uncontrollable hypertension e)Arrhythmia 17)Systemic infection 18)Either HIV ab+, HTLV-1 ab+, HBs ag+ or HCV ab+. 19)History of severe allergic reaction 20)History of organ allotransplantation or allogeneic hematopoietic stem cell transplantation 21)Uncontrollable DM 22)Pregnant or lactating women or possibility of pregnancy 23)It is judged to lack in ability for agreement by complication of such as dementia 24)Any other patients who are regarded as unsuitable for study enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method (1) Progression-free survival (PFS) (2) Overall survival (OS) (3) Time to response (4) Complete response rate (CR) (5) Correlation of evaluation among Cheson 2007, Cheson LUCANO2014 and RECIL2017 Safety 1) Adverse events 2) Laboratory test 3) Vital sign, body weight, SpO2 4) 12-lead electrocardiogram 5) Chest X-ray 6) Performance Status (ECOG)