Peripheral T cell lymphoma
Conditions
Interventions
The administration of nivolumab is conducted for 14 days as 1 course and infused 240mg in day 1 of every cycle. The dose of nivolumab is not increase or reduced in this study. The treatment can be re
Sponsors
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who was histopathologically diagnosed as the following T cell lymphoma(TCL)(including extranodal NK/TCL) /Peripheral TCL, NOS /Angioimmunoblastic TCL /ALK positive anaplastic large cell lymphoma(ALCL) /ALK negative ALCL /Enteropathy-associated TCL /Hepatosplenic TCL /Subcutaneous panniculitis-like TCL /Extranodal NK/TCL, nasal type 2)Patients with PTCL cutaneous lesions <10% of body surface area 3)Patients with measurable legion Meet all following criteria. Lymph node as lymphoma lesion or nodal mass of extranodal organ diagnosed by CT imaging. Clearly measurable the size in 2 perpendicular dimensions with a CT section image. longer axis >=1.5cm in CT section image, or if longer axis is <1.5cm, short axis is >1.0cm 4)More than 2 regimens history by systemic anticancer drug 5)Pre-treatment history by brentuximab vedotin or the drug is inappropriate about CD30-positive ALCL 6)Patients who were provided PD or response(CR or PR)during with systemic antineoplastic treatment, or patients who recurred or aggravated again after systemic antineoplastic treatment 7)Patients who can provide tumor tissue sample for central pathological diagnosis 8)ECOG PS 0-1 9)More than 3 months survival 10)Sufficient renal function - Cre <=1.5xULN or CCL >=40mL/min 11)Sufficient hepatic function -TB <=1.5xULN -Albumin >=3.0g/dL -AST and ALT <=3xULN 12)Sufficient bone marrow function -Neutrophil >=1.5x103/uL(1.5x109/L) -Platelets >=7.5x104/uL -Hg >=8.0g/dL 13)Female childbearing patients agree to the double contraception after informed consent and at least 5 months after nivolumab administration completion. In addition, patient who can agree to not nursing after informed consent and at least 5 months after nivolumab administration completion 14)Male patients who can agree to the double contraception after nivolumab administration start and at least 7 months after nivolumab administration completion 15)Age of 20 years old or more 16)Patients providing written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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) | — |
Countries
Japan
Contacts
Public ContactKoji Kato
Kyushu University Hospital Department of Hematology, Oncology and Cardiovascular Medicine
Outcome results
None listed