UMIN-CTR Clinical Trial

Basic information
Public title	An ancillary study of '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-A study
Scientific Title	An ancillary study of '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-A 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 explore the biomarkers those can be predicted the response of nivolumab in patients with PTCL to compare patients with and without good ORR, OS and PFS in clinical trial.
Basic objectives2	Others
Basic objectives -Others	Biomarker exploration (gene and protein expression, gene mutation, lymphocyte subset analysis, serum cytokine and chemokine, HLA gene, single cell analysis)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gene and protein expression, gene mutation, lymphocyte subset analysis, serum cytokine and chemokine, HLA gene, single cell analysis
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 enrolled in W-JHS NHL02 2)Patients providing the written informed consent. 3)Patients whose specimens for any test in 'biomarker exploration' can be submitted
Key exclusion criteria	Nothing particular
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 Ethics Committee
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 07 Month 18 Day
Date of IRB	2018 Year 07 Month 18 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2025 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) Gene and protein expression 1) RNA expression analysis 2) Protein expression analysis (2) Gene mutation (3) Lymphocyte subset analysis 1) T cell phenotype assay using flow cytometry and CyTOF 2) Immune checkpoint molecule expression (4) Serum cytokine and chemokine Eotaxin, FGF-2, G-CSF, GM-CSF, IFN-gamma, IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17, IP-10, MCP-1, MIP-1alfa, MIP-1beta, PDGF-BB, RANTES,TNF-alfa,VEGF (5) HLA gene HLA-A,B,C,DRB1,DRB3/4/5,DQA1,DQB1,DPA1,DPB1 gene test (11 loci) (6) Single cell analysis

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=R000039338