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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008793
Receipt No. R000010332
Scientific Title Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)
Date of disclosure of the study information 2012/09/03
Last modified on 2019/03/04

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Basic information
Public title Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)
Acronym Phase II study of remission induction therapy with BR therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.
Scientific Title Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)
Scientific Title:Acronym Phase II study of remission induction therapy with BR therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.
Region
Japan

Condition
Condition follicular lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 After the initial cycles of remission induction therapy with bndamustine and rituximab combination (BR) therapy for the first relapsed follicular lymphoma patients, 90Y-labeled ibritumomab tiuxetan would follow as consolidation therapy for the responder with BR therapy. The objective of this multicenter single arm phase II study is to verify efficacy and safety of induction BR therapy followed by consolidation therapy with 90Y-labeled ibritumomab tiuxetan protocol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (PFS) for 2 years after the completion of ibritumomab tiuxetan therapy
Key secondary outcomes Response rate (RR) after BR therapy
Complete response rate (CRR) after BR therapy
RR after ibritumomab tiuxetan therapy
CRR after ibritumomab tiuxetan therapy
PFS after ibritumomab tiuxetan therapy
2-year overall survival (OS) after ibritumomab tiuxetan therapy
Safety

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 BR therapy for 4 cycles as remission induction therapy.
Ibritumomab tiuxetan therapy for the responded patients as CR, CRu, PR after BR therapy.
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
75 years-old >
Gender Male and Female
Key inclusion criteria Histologically confirmed CD20 positive relapsed follicular lymphoma patients within two previous chemotherapy regimens after diagnosis of the lymphoma.
Aged between 20 or more to 75 or less at registration.
Performance status(ECOG) : 0-2.
Having measurable diseases.
No serious organ damage.
A life expectancy of at least 3 months.
Had to give written informed consent to participate this study.
Key exclusion criteria Histologically confirmed CD20 negative lymphoma by biopsy at the time of diagnosis or relapse.
Having active double or multiple cancer.
Having infectious disease with poor control (including active tuberculosis ).
Having the central nervous system infiltration of the lymphoma.
Intolerant to the drugs using in this study.
If any of HIV antibody, HBs antigen or HCV antibody positivity.
Pregnant (including possibility), nursing women.
Had received bendamustine administration previously.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Kanno
Organization Nara Medical University Hospital
Division name Oncology Center
Zip code
Address Shijo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3052
Email mkanno@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Kanno
Organization Nara Medical University Hospital
Division name Oncology Center
Zip code
Address Shijo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3052
Homepage URL
Email mkanno@naramed-u.ac.jp

Sponsor
Institute Society of Lymphoma Treatment in Japan (SoLTJ)
Institute
Department

Funding Source
Organization Nonprofit Organization, Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 奈良県立医科大学附属病院(奈良県)
山梨県立中央病院(山梨県)
千葉県がんセンター(千葉県)
社会保険紀南病院(和歌山県)
富山市民病院(富山県)
市立旭川病院(北海道)
近畿大学医学部奈良病院(奈良県)
富山県立中央病院(富山県)
新潟大学医歯学総合病院(新潟県)
四国がんセンター(愛媛県)
金沢医科大学病院(石川県)
岡山大学病院(岡山県)
岡山市民病院(岡山県)
公立昭和病院(東京都)
日本大学附属板橋病院(東京都)
多摩北部医療センター(東京都)
中国中央病院(広島県)
九州がんセンター(福岡県)
赤穂中央病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 28 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010332

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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