UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008793 |
|---|---|
| Receipt number | 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 09:44:53 |
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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
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
mkanno@naramed-u.ac.jp
Sponsor or person
Institute
Society of Lymphoma Treatment in Japan (SoLTJ)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010332
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
