UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034499 |
|---|---|
| Receipt number | 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 | 2022/10/18 10:24:21 |
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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 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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039334
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