UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Masatoshi Kanno
Organization	Nara Medical University Hospital
Division name	Oncology Center
Address	Shijo-cho 840, Kashihara, Nara, Japan
TEL	0744-22-3052
Email	mkanno@naramed-u.ac.jp

Public contact
Name of contact person	Masatoshi Kanno
Organization	Nara Medical University Hospital
Division name	Oncology Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010332