UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033794 |
|---|---|
| Receipt number | 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 | 2023/06/16 06:50:15 |
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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.
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 | Yosuke |
| Middle name | |
| Last name | Minami |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
NIVOMAT_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse |
| Middle name | |
| Last name | Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
NIVOMAT_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irboffice@east.ncc.go.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
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（愛知県）
東京医科大学病院（東京都）
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037955
