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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033794
Receipt No. R000037955
Scientific Title Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/22

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Basic information
Public title Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies
Acronym NIVOMAT study
Scientific Title Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies
Scientific Title:Acronym NIVOMAT study
Region
Japan

Condition
Condition malignant lymphoma, myelodysplastic syndromes
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate safety and potential efficacy of Nivolumab in patients with relapsed/refractory Diffuse large B-cell lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Confirmed objective response rate;ORR
Key secondary outcomes Progression-free survival;PFS
Overall survival;OS
Duration of response;DoR
time to response
Rate of Adverse Event

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 Nivolumab (240mg/day) is injected intravenously at Day 1. (One cycle is 14 days).
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 with written informed consent.
2) Be >=20 years of age on the day of signing the informed consent.
3) Patients with Follicular lymphoma or Diffuse large B-cell lymphoma or Extranodal NK/T-cell lymphoma nasal type or myelodysplastic syndrome. patients has been confirmed histologically or cytologically.
4) Recurrent or relapsed after the last chemotherapy is completed or refractory or intolerance to the most recent chemotherapy.
DLBCL patients, the number of previous regimens is 3 or less (High-dose chemotherapy following salvage chemotherapy is not counted as one regimen. ex; patients who relapse after R-CHOP therapy and who underwent high-dose chemotherapy after salvage with ESHAP therapy: 2 regimens).
MDS patients resistant or intolerant to azacitidine.
5) Have an ECOG performance status of 0 or 1.
6) Have one or more evaluable lesions
-Lymphoma: A CT image or MRI image with a lesion whose major axis exceeds 15 mm (a lesion with a minor axis exceeding 10 mm when the major axis is 11 mm or more and 15 mm or less) has clearly measurable lesions in two orthogonal directions
-MDS: Bone marrow aspiration is possible and the proportion of blasts in bone marrow can be assessed
7) Demonstrated adequate organ function. 8) Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9)Women of childbearing potential agree to use double contraception methods from day of the informed consent through at least after 5 months of final administration. Women agree to not to breast-feed from day of the informed consent through at least after 5 months of final administration.
Men agree to take double contraception from day of first dose through at least after 7 months of final administration.
Key exclusion criteria 1) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy within 2weeks prior to enrollment Received immunotherapy within 28 days prior to enrollment.
2) Patients with therapeutic history of immune checkpoint inhibitor
3) Patients with hypertension that is difficult to control despite taking multiple medications
4) Patients with a history or finding of congestive heart failure of NYHA classification III or higher
5) Patients with acute coronary syndrome, coronary angioplasty, or stent placement, within 6 months prior to enrollment.
6) Patients with grade 3 or higher active infections according to CTCAE v 4.0
7) Patients with complication or previous history of interstitial lung disease with active symptoms or signs
8) Patients with autoimmune disease complications or a history of chronic / recurrent autoimmune disease
9) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment.
10) Have type I diabetes, or have type II diabetes mellitus which cannot be adequately controlled by insulin therapy
11) Have history of organ transplantation or allogeneic hematopoietic stem cell transplantation.
12) Patients with seizure disorder requiring drug treatment
13) Grade 3 or more bleeding was confirmed 4 weeks before enrollment
14) Patients with double cancer
15) Major surgery within 2 weeks
16)Patients with wounds, ulcers, or fractures that have not healed
17) Either HIV antibody, HBs antigen or HCV antibody test is positive.
18) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients
19) Pregnant women, lactating women or possibly pregnant women
20) Patients judged unsuitable to evaluation of Nivolumab or interpretation of the result
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Minami
Organization National Cancer Center Hospital East
Division name Department of Hematology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email NIVOMAT_core@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse
Organization National Cancer Center Hospital East
Division name Department of Hematology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email NIVOMAT_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
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
Address
Tel
Email

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 国立がん研究センター東病院(千葉県)
愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 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 06 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037955

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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