UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034502 |
|---|---|
| Receipt number | 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 | 2022/10/18 10:31:35 |
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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
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
kojikato@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039338
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