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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034502
Receipt No. R000039338
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'
Date of disclosure of the study information 2018/10/15
Last modified on 2019/04/16

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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
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 Open public 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
2021 Year 06 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
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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