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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034499
Receipt No. R000039334
Scientific Title 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 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 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
3)More than 2 regimens history by systemic anticancer drug
4)Pre-treatment history by brentuximab vedotin or the drug is inappropriate about CD30-positive ALCL
5)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
6)Patients who can provide tumor tissue sample for central pathological diagnosis
7)ECOG PS 0-1
8)More than 3 months survival
9)Sufficient renal function
- Cre <=1.5xULN or CCL >=40mL/min
10)Sufficient hepatic function
-TB <=1.5xULN
-Albumin >=3.0g/dL
-AST and ALT <=3xULN
11)Sufficient bone marrow function
-Neutrophil >=1.5x103/uL(1.5x109/L)
-Platelets >=7.5x104/uL
-Hg >=8.0g/dL
12)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
13)Male patients who can agree to the double contraception after nivolumab administration start and at least 7 months after nivolumab administration completion
15)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
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 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
2021 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
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=R000039334

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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