UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial.
Acronym	W-JHS NHL02 study
Scientific Title	Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial.
Scientific Title:Acronym	W-JHS NHL02 study
Region	Japan

Condition
Condition	Peripheral T cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of nivolumab monotherapy in patients with extremely prognosis poor recurrent and refractory peripheral T cell lymphoma without standard therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall response rate (ORR)
Key secondary outcomes	(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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 repeated if patients meet all administration criteria of investigational drug and do not meet one of discontinuation criteria. Among all patients receiving investigational drug, the investigators evaluate in the subject corresponding to one of discontinuation criteria of investigational drug (at discontinuation), and patients are shifted for post treatment period.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Akashi
Organization	Kyushu University Graduate School of Medical Science
Division name	Department of Medicine and Biosystemic Science
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5230
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Kato
Organization	Kyushu University Hospital
Division name	Department of Hematology, Oncology and Cardiovascular Medicine
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5230
Homepage URL
Email	kojikato@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NPO Clinical Research Network Fukuoka
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel	092-643-7171
Email	mail@crnfukuoka.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 02 Month 15 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039334